Explore numerous pharmaceutical jobs that offer opportunities in 36 Pharmaceutical jobs in Australia
Medical Science Liaison, Gastroenterology
Melbourne, Victoria
AbbVie
Posted today
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.
Job Description
The Medical Science Liaison (MSL) - Gastroenterology serves to advance science and standards of care for patients through their engagement with healthcare professionals and other stakeholders within the healthcare system. Through scientific engagement, MSLs provide credible, practical and clinically relevant information and solutions to enable both the effective and safe use of AbbVie products. Collectively, as members of GMA, they work to make a remarkable impact on patient care around the world.
MSLs work to communicate information and facilitate dialogue about AbbVie's marketed products, and compounds in development, in a strictly scientific, non-promotional manner, and in full compliance with applicable national laws and regulations, guidelines, codes of conduct, AbbVie's policies and procedures and accepted standards of best practice.
This function is field based (VIC territory). Up to 80% of the time will be spent field-based.
KEY DUTIES AND RESPONSIBILITIES
+ Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie.
+ Ensure a strong medical and scientific presence for AbbVie in key academic centres by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to AbbVie.
+ Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant AbbVie medicines, to support their safe, effective and appropriate use.
+ Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.), where requested.
+ Attend relevant scientific meetings and conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform AbbVie strategic priorities and initiatives.
+ Upon request, assist physicians with requests for access to AbbVie medicines on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.
+ Provide key thought leaders / external experts and internal medical, market access and clinical teams with scientific and technical support for publications of scientific or medical interest.
+ Assist in the site selection, initiation, oversight and follow up of assigned clinical studies and medical projects initiated within the therapeutic area of responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorisation studies (phase IV). All such activities must comply with applicable local laws, guidelines, codes of practice, SOPs, and AbbVie R&D SOPs.
+ Act as the point of contact with thought leaders to facilitate investigator-initiated study (IIS) ideas and requests for support to the local and global medical teams as appropriate.
+ Support internal teams such as sales and marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific update presentations.
+ Participate in the selection process to identify appropriately qualified thought leaders the company would wish to engage in collaborative efforts - such as potential research collaborations, or educational (e.g., congress, symposia) and advisory roles; while ensuring a high level of scientific or educational integrity in these collaborative efforts.
+ Facilitate medical and scientific field intelligence - for example, competitor research and medical strategies, educational activities - and communicate, where appropriate, within the company, including cross-functional gap assessments.
+ Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, company policies and accepted standards of best practice.
+ Report any adverse event within 24 hours as per AbbVie's policies and procedures.
+ Proactively participate in AbbVie's WHS programs, adhere to policies and promote a safe work environment at all times.
+ Adhere to AbbVie's internal codes of conduct and compliance processes.
+ Other ad hoc duties such as administrative duties, as requested.
Qualifications
+ Advanced degree (e.g. B.Pharm, MD, PhD) in a relevant scientific discipline is preferred but candidates with an undergraduate degree in a relevant discipline and demonstrated experience will be considered.
+ Experience in developing and maintaining expert knowledge for the assigned therapeutic area, and in medical research in general.
+ Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company.
+ Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research.
+ Demonstrated ability to develop and maintain relationships with internal and external stakeholders
+ Ability to comprehensively learn about new subject areas and environments.
+ Excellent written and spoken communication and presentation skills, with a demonstrated ability to develop and maintain strong collaborative relationships with thought leaders, physicians and other healthcare decision makers.
+ A good understanding of written and oral English is desirable.
+ High customer orientation.
+ Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
+ Experience working in a pharmaceutical industry and general knowledge on drug development and clinical research an advantage
Flexibility and Availability: In line with Australia's 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.
Additional Information
WAYS WE WORK
+ All For One Abbvie; We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.
+ Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn't work and get on to what does.
+ Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.
+ Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
+ Make Possibilities Real; We question with endless curiosity. We're never satisfied with good enough-patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.
CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT
+ AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.
+ AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.
+ All AbbVie employees are responsible for maintaining the Company's reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law. Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.
+ AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.
Job Description
The Medical Science Liaison (MSL) - Gastroenterology serves to advance science and standards of care for patients through their engagement with healthcare professionals and other stakeholders within the healthcare system. Through scientific engagement, MSLs provide credible, practical and clinically relevant information and solutions to enable both the effective and safe use of AbbVie products. Collectively, as members of GMA, they work to make a remarkable impact on patient care around the world.
MSLs work to communicate information and facilitate dialogue about AbbVie's marketed products, and compounds in development, in a strictly scientific, non-promotional manner, and in full compliance with applicable national laws and regulations, guidelines, codes of conduct, AbbVie's policies and procedures and accepted standards of best practice.
This function is field based (VIC territory). Up to 80% of the time will be spent field-based.
KEY DUTIES AND RESPONSIBILITIES
+ Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie.
+ Ensure a strong medical and scientific presence for AbbVie in key academic centres by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to AbbVie.
+ Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant AbbVie medicines, to support their safe, effective and appropriate use.
+ Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.), where requested.
+ Attend relevant scientific meetings and conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform AbbVie strategic priorities and initiatives.
+ Upon request, assist physicians with requests for access to AbbVie medicines on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.
+ Provide key thought leaders / external experts and internal medical, market access and clinical teams with scientific and technical support for publications of scientific or medical interest.
+ Assist in the site selection, initiation, oversight and follow up of assigned clinical studies and medical projects initiated within the therapeutic area of responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorisation studies (phase IV). All such activities must comply with applicable local laws, guidelines, codes of practice, SOPs, and AbbVie R&D SOPs.
+ Act as the point of contact with thought leaders to facilitate investigator-initiated study (IIS) ideas and requests for support to the local and global medical teams as appropriate.
+ Support internal teams such as sales and marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific update presentations.
+ Participate in the selection process to identify appropriately qualified thought leaders the company would wish to engage in collaborative efforts - such as potential research collaborations, or educational (e.g., congress, symposia) and advisory roles; while ensuring a high level of scientific or educational integrity in these collaborative efforts.
+ Facilitate medical and scientific field intelligence - for example, competitor research and medical strategies, educational activities - and communicate, where appropriate, within the company, including cross-functional gap assessments.
+ Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, company policies and accepted standards of best practice.
+ Report any adverse event within 24 hours as per AbbVie's policies and procedures.
+ Proactively participate in AbbVie's WHS programs, adhere to policies and promote a safe work environment at all times.
+ Adhere to AbbVie's internal codes of conduct and compliance processes.
+ Other ad hoc duties such as administrative duties, as requested.
Qualifications
+ Advanced degree (e.g. B.Pharm, MD, PhD) in a relevant scientific discipline is preferred but candidates with an undergraduate degree in a relevant discipline and demonstrated experience will be considered.
+ Experience in developing and maintaining expert knowledge for the assigned therapeutic area, and in medical research in general.
+ Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company.
+ Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research.
+ Demonstrated ability to develop and maintain relationships with internal and external stakeholders
+ Ability to comprehensively learn about new subject areas and environments.
+ Excellent written and spoken communication and presentation skills, with a demonstrated ability to develop and maintain strong collaborative relationships with thought leaders, physicians and other healthcare decision makers.
+ A good understanding of written and oral English is desirable.
+ High customer orientation.
+ Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
+ Experience working in a pharmaceutical industry and general knowledge on drug development and clinical research an advantage
Flexibility and Availability: In line with Australia's 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.
Additional Information
WAYS WE WORK
+ All For One Abbvie; We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.
+ Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn't work and get on to what does.
+ Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.
+ Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
+ Make Possibilities Real; We question with endless curiosity. We're never satisfied with good enough-patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.
CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT
+ AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.
+ AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.
+ All AbbVie employees are responsible for maintaining the Company's reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law. Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.
+ AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
0
Clinical Research Associate (CRA) II/ Senior CRA (FSP) | Melbourne, Sydney, Brisbane
Melbourne, Victoria
ThermoFisher Scientific
Posted 1 day ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Summarized Purpose:**
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**Location Information**
This is a home-based position and preferably based in **Melbourne, Sydney or Brisbane.**
**Key responsibilities**
+ Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
+ Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
+ Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
+ Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
+ Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
+ Responds to company, client and applicable regulatory requirements/audits/inspections.
+ Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
+ Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
+ Contributes to other project work and initiatives for process improvement, as required.
**Keys to Success**
**Education and Experience:**
+ Bachelor's degree in a life sciences related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. Valid driver's license where applicable.
+ **Therapeutic experience in Oncology essential**
+ **Phase I experience essential**
**Knowledge, Skills and Abilities:**
+ Proven clinical monitoring skills.
+ Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
+ Demonstrated ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations and procedural documents.
+ Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
+ Ability to manage Risk Based Monitoring concepts and processes.
+ Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
+ Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues.
+ Good organizational and time management skills
+ Effective interpersonal skills.
+ Attention to detail.
+ Ability to remain flexible and adaptable in a wide range of scenarios.
+ Ability to work in a team or independently as required.
+ Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
+ Good English language and grammar skills.
+ Good presentation skills.
+ Australian citizenship or permanent residency required
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchaseadditional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific** **Australia** **W** **GEA Employer of Choice for Gender Equality**
We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Summarized Purpose:**
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**Location Information**
This is a home-based position and preferably based in **Melbourne, Sydney or Brisbane.**
**Key responsibilities**
+ Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
+ Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
+ Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
+ Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
+ Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
+ Responds to company, client and applicable regulatory requirements/audits/inspections.
+ Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
+ Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
+ Contributes to other project work and initiatives for process improvement, as required.
**Keys to Success**
**Education and Experience:**
+ Bachelor's degree in a life sciences related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. Valid driver's license where applicable.
+ **Therapeutic experience in Oncology essential**
+ **Phase I experience essential**
**Knowledge, Skills and Abilities:**
+ Proven clinical monitoring skills.
+ Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
+ Demonstrated ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations and procedural documents.
+ Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
+ Ability to manage Risk Based Monitoring concepts and processes.
+ Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
+ Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues.
+ Good organizational and time management skills
+ Effective interpersonal skills.
+ Attention to detail.
+ Ability to remain flexible and adaptable in a wide range of scenarios.
+ Ability to work in a team or independently as required.
+ Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
+ Good English language and grammar skills.
+ Good presentation skills.
+ Australian citizenship or permanent residency required
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchaseadditional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific** **Australia** **W** **GEA Employer of Choice for Gender Equality**
We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
1
Clinical Research Associate (CRA) II/ Senior CRA (FSP) | Melbourne, Sydney, Brisbane
Brisbane, Queensland
ThermoFisher Scientific
Posted 1 day ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Summarized Purpose:**
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**Location Information**
This is a home-based position and preferably based in **Melbourne, Sydney or Brisbane.**
**Key responsibilities**
+ Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
+ Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
+ Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
+ Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
+ Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
+ Responds to company, client and applicable regulatory requirements/audits/inspections.
+ Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
+ Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
+ Contributes to other project work and initiatives for process improvement, as required.
**Keys to Success**
**Education and Experience:**
+ Bachelor's degree in a life sciences related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. Valid driver's license where applicable.
+ **Therapeutic experience in Oncology essential**
+ **Phase I experience essential**
**Knowledge, Skills and Abilities:**
+ Proven clinical monitoring skills.
+ Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
+ Demonstrated ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations and procedural documents.
+ Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
+ Ability to manage Risk Based Monitoring concepts and processes.
+ Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
+ Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues.
+ Good organizational and time management skills
+ Effective interpersonal skills.
+ Attention to detail.
+ Ability to remain flexible and adaptable in a wide range of scenarios.
+ Ability to work in a team or independently as required.
+ Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
+ Good English language and grammar skills.
+ Good presentation skills.
+ Australian citizenship or permanent residency required
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchaseadditional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific** **Australia** **W** **GEA Employer of Choice for Gender Equality**
We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Summarized Purpose:**
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**Location Information**
This is a home-based position and preferably based in **Melbourne, Sydney or Brisbane.**
**Key responsibilities**
+ Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
+ Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
+ Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
+ Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
+ Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
+ Responds to company, client and applicable regulatory requirements/audits/inspections.
+ Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
+ Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
+ Contributes to other project work and initiatives for process improvement, as required.
**Keys to Success**
**Education and Experience:**
+ Bachelor's degree in a life sciences related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. Valid driver's license where applicable.
+ **Therapeutic experience in Oncology essential**
+ **Phase I experience essential**
**Knowledge, Skills and Abilities:**
+ Proven clinical monitoring skills.
+ Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
+ Demonstrated ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations and procedural documents.
+ Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
+ Ability to manage Risk Based Monitoring concepts and processes.
+ Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
+ Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues.
+ Good organizational and time management skills
+ Effective interpersonal skills.
+ Attention to detail.
+ Ability to remain flexible and adaptable in a wide range of scenarios.
+ Ability to work in a team or independently as required.
+ Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
+ Good English language and grammar skills.
+ Good presentation skills.
+ Australian citizenship or permanent residency required
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchaseadditional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific** **Australia** **W** **GEA Employer of Choice for Gender Equality**
We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
2
Clinical Research Associate (CRA) II/ Senior CRA (FSP) | Melbourne, Sydney, Brisbane
Sydney, New South Wales
ThermoFisher Scientific
Posted 1 day ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Summarized Purpose:**
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**Location Information**
This is a home-based position and preferably based in **Melbourne, Sydney or Brisbane.**
**Key responsibilities**
+ Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
+ Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
+ Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
+ Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
+ Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
+ Responds to company, client and applicable regulatory requirements/audits/inspections.
+ Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
+ Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
+ Contributes to other project work and initiatives for process improvement, as required.
**Keys to Success**
**Education and Experience:**
+ Bachelor's degree in a life sciences related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. Valid driver's license where applicable.
+ **Therapeutic experience in Oncology essential**
+ **Phase I experience essential**
**Knowledge, Skills and Abilities:**
+ Proven clinical monitoring skills.
+ Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
+ Demonstrated ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations and procedural documents.
+ Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
+ Ability to manage Risk Based Monitoring concepts and processes.
+ Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
+ Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues.
+ Good organizational and time management skills
+ Effective interpersonal skills.
+ Attention to detail.
+ Ability to remain flexible and adaptable in a wide range of scenarios.
+ Ability to work in a team or independently as required.
+ Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
+ Good English language and grammar skills.
+ Good presentation skills.
+ Australian citizenship or permanent residency required
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchaseadditional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific** **Australia** **W** **GEA Employer of Choice for Gender Equality**
We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Summarized Purpose:**
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**Location Information**
This is a home-based position and preferably based in **Melbourne, Sydney or Brisbane.**
**Key responsibilities**
+ Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
+ Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
+ Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
+ Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
+ Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
+ Responds to company, client and applicable regulatory requirements/audits/inspections.
+ Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
+ Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
+ Contributes to other project work and initiatives for process improvement, as required.
**Keys to Success**
**Education and Experience:**
+ Bachelor's degree in a life sciences related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. Valid driver's license where applicable.
+ **Therapeutic experience in Oncology essential**
+ **Phase I experience essential**
**Knowledge, Skills and Abilities:**
+ Proven clinical monitoring skills.
+ Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
+ Demonstrated ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations and procedural documents.
+ Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
+ Ability to manage Risk Based Monitoring concepts and processes.
+ Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
+ Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues.
+ Good organizational and time management skills
+ Effective interpersonal skills.
+ Attention to detail.
+ Ability to remain flexible and adaptable in a wide range of scenarios.
+ Ability to work in a team or independently as required.
+ Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
+ Good English language and grammar skills.
+ Good presentation skills.
+ Australian citizenship or permanent residency required
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchaseadditional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific** **Australia** **W** **GEA Employer of Choice for Gender Equality**
We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
3
Regulatory Affairs Lead
St Leonards, New South Wales
Stryker
Posted 1 day ago
Job Viewed
Job Description
**About the role:**
The Regulatory Affairs Lead is responsible for overseeing and driving key regulatory activities for Stryker South Pacific, ensuring compliance with relevant regulations and legislation.
This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point of escalation for complex regulatory matters. Additionally, the Regulatory Affairs Lead will coach and mentor team members, providing guidance to support their professional development.
**About you:**
You're a sharp, commercially minded professional with experience navigating complex, highly regulated environments - whether that's FMCG, Alcohol, Financial Services, Pharma, Life Sciences, or similar. You may not come from a traditional Regulatory Affairs or medical device background, and that's okay. What matters is your ability to think strategically, influence stakeholders, and solve problems with confidence and care.
You're ready to step into a role that blends compliance with commercial impact. You're a natural relationship builder, a persuasive communicator, and a curious learner who thrives in complex, fast-paced environments. You may not have led a team yet, but you're hungry to grow into leadership-and we're ready to support that journey.
**Key responsibilities**
+ **Strategic regulatory guidance:** Advise on product registration pathways, regulatory strategies, and business acquisitions to accelerate speed to market and align with commercial goals;
+ **Risk management and compliance:** Identify and mitigate regulatory risks while ensuring compliance with legislation, standards, and internal procedures. Support post-market activities and change management initiatives;
+ **Process improvement and implementation:** Lead the rollout of new regulatory processes and contribute to continuous improvement efforts that enhance compliance and operational efficiency;
+ **Stakeholder engagement and issue resolution:** Act as a trusted escalation point for complex regulatory issues. Collaborate cross-functionally to resolve challenges and deliver strategic solutions **;** and
+ **Leadership and team development:** Coach and support peers and junior team members, building technical capability and fostering a culture of growth and learning.
**Must have experience/skills:**
We're looking for someone with a unique blend of skills and mindset. You'll thrive here if you have:
+ Exposure to highly regulated industries and a strong understanding of compliance frameworks;
+ Tertiary qualifications in a related discipline;
+ Excellent communication, negotiation, and influencing skills;
+ A strategic mindset with the ability to balance detail and big-picture thinking;
+ A collaborative style and the ability to navigate competing priorities;
+ A passion for continuous improvement and smarter ways of working; and
+ An interest in coaching, mentoring and developing teams with a desire to grow into leadership in future.
**Desired but not essential experience/skills:**
If you've got any of the following, that's a plus-but not a dealbreaker:
+ Experience in medical device regulatory affairs (Australia, NZ, FDA, EU MDR);
+ Familiarity with Prostheses List management; and
+ Prior team management or mentoring experience.
**To join us, click apply now!**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
The Regulatory Affairs Lead is responsible for overseeing and driving key regulatory activities for Stryker South Pacific, ensuring compliance with relevant regulations and legislation.
This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point of escalation for complex regulatory matters. Additionally, the Regulatory Affairs Lead will coach and mentor team members, providing guidance to support their professional development.
**About you:**
You're a sharp, commercially minded professional with experience navigating complex, highly regulated environments - whether that's FMCG, Alcohol, Financial Services, Pharma, Life Sciences, or similar. You may not come from a traditional Regulatory Affairs or medical device background, and that's okay. What matters is your ability to think strategically, influence stakeholders, and solve problems with confidence and care.
You're ready to step into a role that blends compliance with commercial impact. You're a natural relationship builder, a persuasive communicator, and a curious learner who thrives in complex, fast-paced environments. You may not have led a team yet, but you're hungry to grow into leadership-and we're ready to support that journey.
**Key responsibilities**
+ **Strategic regulatory guidance:** Advise on product registration pathways, regulatory strategies, and business acquisitions to accelerate speed to market and align with commercial goals;
+ **Risk management and compliance:** Identify and mitigate regulatory risks while ensuring compliance with legislation, standards, and internal procedures. Support post-market activities and change management initiatives;
+ **Process improvement and implementation:** Lead the rollout of new regulatory processes and contribute to continuous improvement efforts that enhance compliance and operational efficiency;
+ **Stakeholder engagement and issue resolution:** Act as a trusted escalation point for complex regulatory issues. Collaborate cross-functionally to resolve challenges and deliver strategic solutions **;** and
+ **Leadership and team development:** Coach and support peers and junior team members, building technical capability and fostering a culture of growth and learning.
**Must have experience/skills:**
We're looking for someone with a unique blend of skills and mindset. You'll thrive here if you have:
+ Exposure to highly regulated industries and a strong understanding of compliance frameworks;
+ Tertiary qualifications in a related discipline;
+ Excellent communication, negotiation, and influencing skills;
+ A strategic mindset with the ability to balance detail and big-picture thinking;
+ A collaborative style and the ability to navigate competing priorities;
+ A passion for continuous improvement and smarter ways of working; and
+ An interest in coaching, mentoring and developing teams with a desire to grow into leadership in future.
**Desired but not essential experience/skills:**
If you've got any of the following, that's a plus-but not a dealbreaker:
+ Experience in medical device regulatory affairs (Australia, NZ, FDA, EU MDR);
+ Familiarity with Prostheses List management; and
+ Prior team management or mentoring experience.
**To join us, click apply now!**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
This advertiser has chosen not to accept applicants from your region.
4
Clinical Research Associate
Melbourne, Victoria
ICON Clinical Research
Posted 3 days ago
Job Viewed
Job Description
Clinical Research Associate - Home-based in Australia
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Associate (CRA) to join our diverse and dynamic team. As a CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
**What You Will Be Doing:**
+ Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
+ Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
+ Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
+ Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
+ Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
**Your Profile:**
+ Advanced degree in a relevant field such as life sciences, nursing, or medicine.
+ Extensive experience as a Clinical Research Associate, (min. 2 years of independent monitoring experience) with a strong understanding of clinical trial processes and regulatory requirements.
+ Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
+ Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
+ Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Associate (CRA) to join our diverse and dynamic team. As a CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
**What You Will Be Doing:**
+ Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
+ Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
+ Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
+ Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
+ Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
**Your Profile:**
+ Advanced degree in a relevant field such as life sciences, nursing, or medicine.
+ Extensive experience as a Clinical Research Associate, (min. 2 years of independent monitoring experience) with a strong understanding of clinical trial processes and regulatory requirements.
+ Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
+ Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
+ Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
This advertiser has chosen not to accept applicants from your region.
5
Clinical Trial Coordinator | Perth, Adelaide, Sydney, Brisbane
Adelaide, South Australia
ThermoFisher Scientific
Posted 4 days ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
This home-based position requires candidates to reside in Perth, Brisbane, Sydney, Adelaide.
**Discover Impactful Work:**
The Clinical Trial Coordinator, (CTC) provides administrative and file management support to their assigned study teams. The CTC ensures the study documents are tracked, filed and updated in a timely manner. They are responsible for ensuring the documents meet quality standards, that the files are complete and accurate, and that the documents are current. CTCs participate in reconciling document issues throughout the study and following scheduled file reviews. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations.
A day in the Life:
+ Performs Department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
+ Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
+ Provides system support (i.e., CTMS, Activate & eTMF) and ensures system databases are always current.
+ Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ May support scheduling of client and/or internal meetings.
+ May review and track local regulatory documents.
+ Maintains vendor trackers.
+ Supports start-up team in Regulatory submissions.
+ Works directly with sites to obtain documents related to site selection.
+ Provides administrative support including but not limited to, printing documents for site files, arranging couriers to and from sites, managing returns of non-investigational project specific supplies if required.
+ Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
**Keys to Success:**
**Education**
+ Bachelor's degree is the minimum requirement, preferably in the area of health/medical science or nursing.
**Experience**
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
**Knowledge, Skills, Abilities**
+ Ability to work in a team or independently as required.
+ Flexibility to reprioritize workload to meet changing project timelines.
+ Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
+ Good English language and grammar skills.
+ Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to learn and utilise applicable clinical trial database systems.
+ Effective oral and written communication skills.
+ Crucial judgment and decision-making skills.
+ Capable of accurately following project work instructions.
+ Ablity to work independently and complete tasks on time and to a high standard.
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require travel. (Recruiter will provide more details.)
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality**
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
This home-based position requires candidates to reside in Perth, Brisbane, Sydney, Adelaide.
**Discover Impactful Work:**
The Clinical Trial Coordinator, (CTC) provides administrative and file management support to their assigned study teams. The CTC ensures the study documents are tracked, filed and updated in a timely manner. They are responsible for ensuring the documents meet quality standards, that the files are complete and accurate, and that the documents are current. CTCs participate in reconciling document issues throughout the study and following scheduled file reviews. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations.
A day in the Life:
+ Performs Department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
+ Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
+ Provides system support (i.e., CTMS, Activate & eTMF) and ensures system databases are always current.
+ Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ May support scheduling of client and/or internal meetings.
+ May review and track local regulatory documents.
+ Maintains vendor trackers.
+ Supports start-up team in Regulatory submissions.
+ Works directly with sites to obtain documents related to site selection.
+ Provides administrative support including but not limited to, printing documents for site files, arranging couriers to and from sites, managing returns of non-investigational project specific supplies if required.
+ Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
**Keys to Success:**
**Education**
+ Bachelor's degree is the minimum requirement, preferably in the area of health/medical science or nursing.
**Experience**
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
**Knowledge, Skills, Abilities**
+ Ability to work in a team or independently as required.
+ Flexibility to reprioritize workload to meet changing project timelines.
+ Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
+ Good English language and grammar skills.
+ Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to learn and utilise applicable clinical trial database systems.
+ Effective oral and written communication skills.
+ Crucial judgment and decision-making skills.
+ Capable of accurately following project work instructions.
+ Ablity to work independently and complete tasks on time and to a high standard.
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require travel. (Recruiter will provide more details.)
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality**
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
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6
Clinical Trial Coordinator | Perth, Adelaide, Sydney, Brisbane
Brisbane, Queensland
ThermoFisher Scientific
Posted 4 days ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
This home-based position requires candidates to reside in Perth, Brisbane, Sydney, Adelaide.
**Discover Impactful Work:**
The Clinical Trial Coordinator, (CTC) provides administrative and file management support to their assigned study teams. The CTC ensures the study documents are tracked, filed and updated in a timely manner. They are responsible for ensuring the documents meet quality standards, that the files are complete and accurate, and that the documents are current. CTCs participate in reconciling document issues throughout the study and following scheduled file reviews. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations.
A day in the Life:
+ Performs Department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
+ Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
+ Provides system support (i.e., CTMS, Activate & eTMF) and ensures system databases are always current.
+ Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ May support scheduling of client and/or internal meetings.
+ May review and track local regulatory documents.
+ Maintains vendor trackers.
+ Supports start-up team in Regulatory submissions.
+ Works directly with sites to obtain documents related to site selection.
+ Provides administrative support including but not limited to, printing documents for site files, arranging couriers to and from sites, managing returns of non-investigational project specific supplies if required.
+ Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
**Keys to Success:**
**Education**
+ Bachelor's degree is the minimum requirement, preferably in the area of health/medical science or nursing.
**Experience**
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
**Knowledge, Skills, Abilities**
+ Ability to work in a team or independently as required.
+ Flexibility to reprioritize workload to meet changing project timelines.
+ Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
+ Good English language and grammar skills.
+ Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to learn and utilise applicable clinical trial database systems.
+ Effective oral and written communication skills.
+ Crucial judgment and decision-making skills.
+ Capable of accurately following project work instructions.
+ Ablity to work independently and complete tasks on time and to a high standard.
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require travel. (Recruiter will provide more details.)
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality**
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
This home-based position requires candidates to reside in Perth, Brisbane, Sydney, Adelaide.
**Discover Impactful Work:**
The Clinical Trial Coordinator, (CTC) provides administrative and file management support to their assigned study teams. The CTC ensures the study documents are tracked, filed and updated in a timely manner. They are responsible for ensuring the documents meet quality standards, that the files are complete and accurate, and that the documents are current. CTCs participate in reconciling document issues throughout the study and following scheduled file reviews. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations.
A day in the Life:
+ Performs Department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
+ Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
+ Provides system support (i.e., CTMS, Activate & eTMF) and ensures system databases are always current.
+ Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ May support scheduling of client and/or internal meetings.
+ May review and track local regulatory documents.
+ Maintains vendor trackers.
+ Supports start-up team in Regulatory submissions.
+ Works directly with sites to obtain documents related to site selection.
+ Provides administrative support including but not limited to, printing documents for site files, arranging couriers to and from sites, managing returns of non-investigational project specific supplies if required.
+ Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
**Keys to Success:**
**Education**
+ Bachelor's degree is the minimum requirement, preferably in the area of health/medical science or nursing.
**Experience**
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
**Knowledge, Skills, Abilities**
+ Ability to work in a team or independently as required.
+ Flexibility to reprioritize workload to meet changing project timelines.
+ Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
+ Good English language and grammar skills.
+ Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to learn and utilise applicable clinical trial database systems.
+ Effective oral and written communication skills.
+ Crucial judgment and decision-making skills.
+ Capable of accurately following project work instructions.
+ Ablity to work independently and complete tasks on time and to a high standard.
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require travel. (Recruiter will provide more details.)
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality**
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
7
Clinical Trial Coordinator | Perth, Adelaide, Sydney, Brisbane
ThermoFisher Scientific
Posted 4 days ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
This home-based position requires candidates to reside in Perth, Brisbane, Sydney, Adelaide.
**Discover Impactful Work:**
The Clinical Trial Coordinator, (CTC) provides administrative and file management support to their assigned study teams. The CTC ensures the study documents are tracked, filed and updated in a timely manner. They are responsible for ensuring the documents meet quality standards, that the files are complete and accurate, and that the documents are current. CTCs participate in reconciling document issues throughout the study and following scheduled file reviews. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations.
A day in the Life:
+ Performs Department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
+ Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
+ Provides system support (i.e., CTMS, Activate & eTMF) and ensures system databases are always current.
+ Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ May support scheduling of client and/or internal meetings.
+ May review and track local regulatory documents.
+ Maintains vendor trackers.
+ Supports start-up team in Regulatory submissions.
+ Works directly with sites to obtain documents related to site selection.
+ Provides administrative support including but not limited to, printing documents for site files, arranging couriers to and from sites, managing returns of non-investigational project specific supplies if required.
+ Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
**Keys to Success:**
**Education**
+ Bachelor's degree is the minimum requirement, preferably in the area of health/medical science or nursing.
**Experience**
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
**Knowledge, Skills, Abilities**
+ Ability to work in a team or independently as required.
+ Flexibility to reprioritize workload to meet changing project timelines.
+ Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
+ Good English language and grammar skills.
+ Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to learn and utilise applicable clinical trial database systems.
+ Effective oral and written communication skills.
+ Crucial judgment and decision-making skills.
+ Capable of accurately following project work instructions.
+ Ablity to work independently and complete tasks on time and to a high standard.
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require travel. (Recruiter will provide more details.)
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality**
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
This home-based position requires candidates to reside in Perth, Brisbane, Sydney, Adelaide.
**Discover Impactful Work:**
The Clinical Trial Coordinator, (CTC) provides administrative and file management support to their assigned study teams. The CTC ensures the study documents are tracked, filed and updated in a timely manner. They are responsible for ensuring the documents meet quality standards, that the files are complete and accurate, and that the documents are current. CTCs participate in reconciling document issues throughout the study and following scheduled file reviews. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations.
A day in the Life:
+ Performs Department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
+ Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
+ Provides system support (i.e., CTMS, Activate & eTMF) and ensures system databases are always current.
+ Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ May support scheduling of client and/or internal meetings.
+ May review and track local regulatory documents.
+ Maintains vendor trackers.
+ Supports start-up team in Regulatory submissions.
+ Works directly with sites to obtain documents related to site selection.
+ Provides administrative support including but not limited to, printing documents for site files, arranging couriers to and from sites, managing returns of non-investigational project specific supplies if required.
+ Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
**Keys to Success:**
**Education**
+ Bachelor's degree is the minimum requirement, preferably in the area of health/medical science or nursing.
**Experience**
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
**Knowledge, Skills, Abilities**
+ Ability to work in a team or independently as required.
+ Flexibility to reprioritize workload to meet changing project timelines.
+ Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
+ Good English language and grammar skills.
+ Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to learn and utilise applicable clinical trial database systems.
+ Effective oral and written communication skills.
+ Crucial judgment and decision-making skills.
+ Capable of accurately following project work instructions.
+ Ablity to work independently and complete tasks on time and to a high standard.
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require travel. (Recruiter will provide more details.)
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:** Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:** Balance your work and personal life with flexible arrangements.
+ **Extra Leave:** Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:** Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:** Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality**
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
8
Senior Regulatory Affairs Specialist
Sydney, New South Wales
Abbott
Posted 4 days ago
Job Viewed
Job Description
**About Abbott**
**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**
**Working at Abbott**
**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:**
**Career development with an international company where you can grow the career you dream of .**
**Amazing health and wellness benefits and perks.**
**A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.**
**A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**
**We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.**
**Overview**
**This role is responsible for the primary responsibility of regulatory activities in Australia and New Zealand. Including managing the regulatory submissions and product updates, approving advertising materials and being responsible for regulatory and legislation changes.**
**Responsibilities**
**Manage all aspects of product registration with regulatory authorities in Australia and New Zealand to ensure regulatory approvals are achieved in accordance with Company objectives. Monitor progress of applications through the regulatory system.**
**Be the main contact for TGA and Medsafe to facilitate evaluation and other regulatory processes.**
**Provide assessment on product and manufacturing changes in relation to regulatory actions.**
**Review and approving promotional material for compliance with relevant regulations and codes.**
**Be the SME of all Australian and New Zeal and Therapeutic Goods regulations and providing guidance and strategy for Affiliate and Global stakeholders**
**Provide training and guidance on Regulatory topics to stakeholders where applicable.**
**Maintain good working knowledge of relevant Federal and State Regulations and standard guidelines and procedures.**
**You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences. These events may take place on an evening and/or weekend.**
**Qualifications and Experience**
**Essential**
**Science Degree or equivalent**
**Minimum 7 years Regulatory experience within the medical devices or IVD industry.**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**
**Working at Abbott**
**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:**
**Career development with an international company where you can grow the career you dream of .**
**Amazing health and wellness benefits and perks.**
**A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.**
**A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**
**We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.**
**Overview**
**This role is responsible for the primary responsibility of regulatory activities in Australia and New Zealand. Including managing the regulatory submissions and product updates, approving advertising materials and being responsible for regulatory and legislation changes.**
**Responsibilities**
**Manage all aspects of product registration with regulatory authorities in Australia and New Zealand to ensure regulatory approvals are achieved in accordance with Company objectives. Monitor progress of applications through the regulatory system.**
**Be the main contact for TGA and Medsafe to facilitate evaluation and other regulatory processes.**
**Provide assessment on product and manufacturing changes in relation to regulatory actions.**
**Review and approving promotional material for compliance with relevant regulations and codes.**
**Be the SME of all Australian and New Zeal and Therapeutic Goods regulations and providing guidance and strategy for Affiliate and Global stakeholders**
**Provide training and guidance on Regulatory topics to stakeholders where applicable.**
**Maintain good working knowledge of relevant Federal and State Regulations and standard guidelines and procedures.**
**You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences. These events may take place on an evening and/or weekend.**
**Qualifications and Experience**
**Essential**
**Science Degree or equivalent**
**Minimum 7 years Regulatory experience within the medical devices or IVD industry.**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
9