15 Pharmaceutical jobs in Australia

Medical Science Liaison

Sanofi Group

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**_Medical Science Liaison - Type 1 Diabetes/ Immunology_**
**Melbourne | 60%+ Travel | Competitive Salary + Car Allowance + Bonus**
Are you an experienced **Medical Science Liaison (MSL)** with a passion for **Type 1 Diabetes and Immunology** ? Join a **global leader in healthcare innovation** where you'll use your scientific expertise to **build partnerships, support clinical research, and improve patient outcomes** .
**_Why You'll Love This Role_**
+ Competitive **salary + car allowance + annual bonus**
+ Opportunity to **influence medical strategy and patient care**
+ Work in a **collaborative, innovative environment** with cross-functional teams
**_About this role_**
In this field-based role, you will partner with healthcare professionals, institutions, and payers in a non-promotional manner, to identify and address there needs to deliver **peer-to-peer scientific engagement.** MSLs use their **scientific expertise** to **communicate and form partnerships** to deliver the medical strategy, capture actionable insights and ultimately improve patient pathways and outcomes.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**_What You'll Do_**
+ Build **trusted, peer-to-peer relationships** with healthcare professionals and institutions
+ **Collaborate** with internal teams to deliver the Country Medical Plan
+ Provide **scientific training and support** for internal stakeholders
+ Support **clinical trial development and execution**
+ Conduct **non-promotional scientific exchange** to address stakeholder needs
+ Gather **actionable insights** to shape strategies, enhance patient pathways and propose solutions.
**_What we are looking for_**
+ Advanced degree in **Medical or Life Sciences** (MD, PharmD, PhD, or Master's)
+ **2+ years' experience** as a Medical Science Liaison
+ Strong knowledge of **Type 1 Diabetes, Immunology, and treatment landscape**
+ Excellent **stakeholder engagement and scientific communication skills**
+ Familiarity with **clinical research, regulatory processes, and digital engagement tools**
+ Willingness to **travel 60%+** within the region
**_Why choose us?_**
Whilst we work hard and aim to lead the market, we also v **alue our people** . As part of the team, you will be encouraged to find balance between high performance and well-being. You will be working with a team known for **supporting personal development and supporting future career aspirations.**
+ Bring the miracles of science to life alongside a **supportive, future-focused team** .
+ **Take good care of yourself and your family** with benefits including prevention and wellness programs.
+ Discover **endless opportunities to grow your talent and drive your career** , whether it's through a promotion or lateral move, at home or internationally.
This is your chance to **advance your MSL career** while contributing to meaningful improvements in patient outcomes.
If you're ready to take the next step in your MSL career, **apply now** and join a company committed to advancing care in Type 1 Diabetes and Immunology.
_At Sanofi,_ **_we embrace a modern hybrid working model that combines the benefits of in-person collaboration with the flexibility of remote work_** _. Our hybrid policy requires three days in the office per week (with one being either Monday or Friday) and offers the flexibility to work remotely for two days weekly_ .
**#LI-ANZ**
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
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Medical Science Liaison

South Melbourne, Victoria Sanofi Group

Posted today

Job Viewed

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Job Description

**_Medical Science Liaison - Type 1 Diabetes/ Immunology_**
**Melbourne | 60%+ Travel | Competitive Salary + Car Allowance + Bonus**
Are you an experienced **Medical Science Liaison (MSL)** with a passion for **Type 1 Diabetes and Immunology** ? Join a **global leader in healthcare innovation** where you'll use your scientific expertise to **build partnerships, support clinical research, and improve patient outcomes** .
**_Why You'll Love This Role_**
+ Competitive **salary + car allowance + annual bonus**
+ Opportunity to **influence medical strategy and patient care**
+ Work in a **collaborative, innovative environment** with cross-functional teams
**_About this role_**
In this field-based role, you will partner with healthcare professionals, institutions, and payers in a non-promotional manner, to identify and address there needs to deliver **peer-to-peer scientific engagement.** MSLs use their **scientific expertise** to **communicate and form partnerships** to deliver the medical strategy, capture actionable insights and ultimately improve patient pathways and outcomes.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**_What You'll Do_**
+ Build **trusted, peer-to-peer relationships** with healthcare professionals and institutions
+ **Collaborate** with internal teams to deliver the Country Medical Plan
+ Provide **scientific training and support** for internal stakeholders
+ Support **clinical trial development and execution**
+ Conduct **non-promotional scientific exchange** to address stakeholder needs
+ Gather **actionable insights** to shape strategies, enhance patient pathways and propose solutions.
**_What we are looking for_**
+ Advanced degree in **Medical or Life Sciences** (MD, PharmD, PhD, or Master's)
+ **2+ years' experience** as a Medical Science Liaison
+ Strong knowledge of **Type 1 Diabetes, Immunology, and treatment landscape**
+ Excellent **stakeholder engagement and scientific communication skills**
+ Familiarity with **clinical research, regulatory processes, and digital engagement tools**
+ Willingness to **travel 60%+** within the region
**_Why choose us?_**
Whilst we work hard and aim to lead the market, we also v **alue our people** . As part of the team, you will be encouraged to find balance between high performance and well-being. You will be working with a team known for **supporting personal development and supporting future career aspirations.**
+ Bring the miracles of science to life alongside a **supportive, future-focused team** .
+ **Take good care of yourself and your family** with benefits including prevention and wellness programs.
+ Discover **endless opportunities to grow your talent and drive your career** , whether it's through a promotion or lateral move, at home or internationally.
This is your chance to **advance your MSL career** while contributing to meaningful improvements in patient outcomes.
If you're ready to take the next step in your MSL career, **apply now** and join a company committed to advancing care in Type 1 Diabetes and Immunology.
_At Sanofi,_ **_we embrace a modern hybrid working model that combines the benefits of in-person collaboration with the flexibility of remote work_** _. Our hybrid policy requires three days in the office per week (with one being either Monday or Friday) and offers the flexibility to work remotely for two days weekly_ .
**#LI-ANZ**
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
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Graduate Clinical Research Associate -Victoria

Richmond, New South Wales Medtronic

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Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
As we enter a new year, applications are now open for recent graduates with a degree in Nursing Biomedical or Health Science to join the Clinical Research Team. As part of this program, you will develop a breadth of experience across the healthcare continuum, working alongside a group of professionals where you will gain best in class training and mentorship at an individual and team level.
At Medtronic, no two days will be the same, in the role you will be able to work with many different teams, learn about breakthrough therapies and see the impact they have on patients. You will be involved in supporting the administrative and clinical trial execution needs of the studies that you work on and make an impact on the future medical needs of our patients. This is the team that works with the frontline technologies. This role will enable you to navigate through challenging scenarios, develop your leadership and resilience skills, as well as develop an eye for detail that will allow you to excel in this and future roles. You will gain insight in to various parts of the product life cycle and you will see first hand the impact you can make using advanced technologies.
**Responsibilities may include the following and other duties may be assigned:**
+ Provide support for the execution of Medtronic clinical trials program
+ Responsible for performing and supporting research for teams operating within the clinical research team
+ Assists with the development, monitoring, coordination, and implementation of non-technical projects as assigned.
+ Provides analysis, reporting and internal communication services with team members.
+ Develops knowledge of industry and organizational processes.
+ Exposure to clinical trials processes and execution
**Required Knowledge and Experience:**
+ Bachelor's Degree in Nursing, Biomedical or Health Sciences graduate with a thirst for knowledge and a keen interest in medical device
+ Being a proactive thinker and problem solver
+ Having a strong collaborative approach and an ability to work across different teams
+ Excellent communication skills
+ A willingness and enthusiasm to learn new concepts with a growth mindset
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
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Clinical Research Associate 2

North Sydney, New South Wales IQVIA

Posted 1 day ago

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Job Description

Are you passionate about science, driven by purpose, and ready to make a real impact in the world of clinical research? We're looking for a Clinical Research Associate 2 who's ready to take their career to the next level-working on cutting-edge studies that shape the future of medicine. Ideally Sydney or Melbourne. Positions available in our Core and Single sponsor team.
Please note as part of the assessment you will be asked to complete a short video screening interview.
**Essential Functions:**
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**What You Bring**
+ A degree in life sciences or healthcare (or equivalent experience).
+ 18 months minimum on-site Independant monitoring experience to be considered, ideally oncology
+ Deep knowledge of GCP, ICH, and clinical trial operations.
+ Tech-savvy with Microsoft Office and mobile tools (iPhone/iPad).
+ A proactive mindset, strong communication skills, and a passion for excellence.
**Why Join Us?**
+ Work ondiverse, global studiesacross multiple therapeutic areas.
+ Be part of asupportive, innovative teamthat values your growth.
+ Enjoyflexible work arrangements, travel opportunities, and career develop
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Clinical Research Associate 2

Melbourne, Victoria IQVIA

Posted 1 day ago

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Job Description

Are you passionate about science, driven by purpose, and ready to make a real impact in the world of clinical research? We're looking for a Clinical Research Associate 2 who's ready to take their career to the next level-working on cutting-edge studies that shape the future of medicine. Ideally Sydney or Melbourne. Positions available in our Core and Single sponsor team.
Please note as part of the assessment you will be asked to complete a short video screening interview.
**Essential Functions:**
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**What You Bring**
+ A degree in life sciences or healthcare (or equivalent experience).
+ 18 months minimum on-site Independant monitoring experience to be considered, ideally oncology
+ Deep knowledge of GCP, ICH, and clinical trial operations.
+ Tech-savvy with Microsoft Office and mobile tools (iPhone/iPad).
+ A proactive mindset, strong communication skills, and a passion for excellence.
**Why Join Us?**
+ Work ondiverse, global studiesacross multiple therapeutic areas.
+ Be part of asupportive, innovative teamthat values your growth.
+ Enjoyflexible work arrangements, travel opportunities, and career develop
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This advertiser has chosen not to accept applicants from your region.

Senior Regulatory Affairs Specialist

Sydney, New South Wales Abbott

Posted 18 days ago

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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
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Regulatory Affairs Lead

St Leonards, New South Wales Stryker

Posted 19 days ago

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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 an experienced regulatory professional with significant experience in a similar Regulatory Affairs role, ideally within the healthcare or medical devices industry (however this is not essential). You will bring a depth of knowledge and experience working within highly regulated industries, interacting with regulatory authorities and navigating complex regulatory environments. You also have strong leadership, strategic thinking, and technical expertise, with a proactive approach and a proven ability to coach teams and influence stakeholders.
**Key responsibilities**
+ **Strategic regulatory guidance:** provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and alignment with commercial goals;
+ **Risk management and compliance:** identify and mitigate regulatory risks, ensuring compliance with legislation, standards and corporate procedures while supporting post-market activities and change management;
+ **Process improvement and implementation:** Drive the implementation of new regulatory processes and contribute to continuous improvement initiatives that enhance compliance and operational efficiency;
+ **Stakeholder engagement and issue resolution:** act as a key escalation point for complex regulatory issues, offering strategic solutions and collaborating across teams to resolve challenges effectives; and
+ **Leadership and team development:** Mentor and coach team members, fostering growth and building technical competency to strengthen regulatory expertise across the team
**Must have experience/skills:**
+ A minimum of 8 years' experience within a Regulatory Affairs, Quality or similar field and demonstrable success in analysis and interpretation of regulatory documentation and technical writing;
+ Tertiary qualifications in a technical discipline (e.g. Science, Engineering, or related.);
+ Strong communication, negotiation and influencing skills - the ability to quickly build meaningful relationships with internal teams, external stakeholders and government departments; and
+ A self-driven, strategic thinker who can balance attention to detail and quality, with the ability to thrive in a fast-paced environment and high performance and growth organisation;
**Desired but not essential experience/skills:**
+ 5+ years of experience in Medical Device regulatory affairs, with a solid understanding of both Australian and international regulatory environments;
+ Strong knowledge of the medical device regulations in Australia and New Zealand. International regulatory knowledge also a plus! (e.g. FDA and EU MDR);
+ Experience with Prostheses List management; and
+ Team management 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.
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Quality Assurance & Regulatory Affairs Associate

Sydney, New South Wales GN Hearing

Posted 19 days ago

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Job Description

Do you thrive in a fast-paced environment where quality and regulatory compliance are key to success? Are you an ISO 13485 expert with a keen eye for risk and continuous improvement? If so, GN Hearing Australia has the perfect opportunity for you!
We're on the lookout for a **Quality Assurance & Regulatory Affairs Associate** to support and elevate our ANZ operations. You'll play a crucial role in ensuring compliance with regulatory standards and GN's global quality management system - while helping improve lives through advanced hearing solutions.
As our QA/RA Associate, you'll:
+ Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates.
+ Support compliance with ISO13485 and local regulatory standards.
+ Act as the local Subject Matter Expert for quality processes and risk assessments.
+ Conduct internal audits and manage CAPAs, NCs, and quality records.
+ Drive validation activities for custom-manufactured products at our Sydney facility.
+ Collaborate with internal teams and corporate stakeholders across the globe.
+ Train and support teams on quality and regulatory matters.
+ Represent the business in local QA/RA meetings and interactions with TGA and other bodies.
+ Be a key player in a high-performing, values-led QA/RA team.
We're looking for someone who:
+ Has a solid understanding of ISO 13485 and quality systems.
+ Knows their way around internal auditing, CAPA, and validation processes.
+ Is confident, detail-oriented, and self-motivated.
+ Communicates effectively with stakeholders at all levels.
+ Has 3+ years' experience in a QA/RA role, ideally in medical devices.
+ Is a natural problem-solver and thrives in a process-driven environment.
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.
GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history - fostering a sense of community, openness, and understanding.
By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them.
**The GN-owned brands that are responsible for bringing these technologies to life:**
+ Medical grade hearing technology: ReSound ( , Beltone ( , Interton ( , Jabra ( Professional collaboration: Jabra ( , BlueParrott ( , FalCom ( Gaming, calls and media: SteelSeries ( , Jabra ( in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN's solutions are sold in around 100 countries across the world.
If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn ( , Facebook ( and Twitter ( .
We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA+ individuals, and persons with disabilities are encouraged to apply. Come join our team!
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Clinical Research Associate 2

North Sydney, New South Wales IQVIA

Posted 19 days ago

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Job Description

Are you passionate about science, driven by purpose, and ready to make a real impact in the world of clinical research? We're looking for a Clinical Research Associate 2 who's ready to take their career to the next level-working on cutting-edge studies that shape the future of medicine. Ideally Sydney or Melbourne. We can not consider sponsorship for this role so please only apply if you currently hold full work rights to work in Australia.
Please note as part of the assessment you will be asked for complete a short video screening interview.
Essential Functions:
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**What You Bring**
+ A degree in life sciences or healthcare (or equivalent experience).
+ 18 months minimum of on-site monitoring experience to be considered ideally oncology
+ Deep knowledge of GCP, ICH, and clinical trial operations.
+ Tech-savvy with Microsoft Office and mobile tools (iPhone/iPad).
+ A proactive mindset, strong communication skills, and a passion for excellence.
**Why Join Us?**
+ Work ondiverse, global studiesacross multiple therapeutic areas.
+ Be part of asupportive, innovative teamthat values your growth.
+ Enjoyflexible work arrangements, travel opportunities, and career develop
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Senior Clinical Research Associate-FSP

Parexel

Posted 19 days ago

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Job Description

**Key Accountabilities:**
**Maintenance (from initiation through close out):**
Act as PAREXEL's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
+ Build relationships with investigators and site staff.
+ Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
+ Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
+ Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
+ Address/evaluate/resolve issues pending from the previous visit, if any.
+ Follow-up on and respond to appropriate site related questions.
+ Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
+ Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
+ Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
+ Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
+ Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
+ Conduct remote visits/contacts as requested/needed.
+ Generate visit/contact report.
+ Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
+ Assess & manage test article/study supply including supply, accountability and destruction/return status.
+ Review & follow-up site payment status.
+ Follow-up on CRF data entry, query status, and SAEs.
+ Conduct on-site study-specific training (if applicable).
+ Perform site facilities assessments
+ Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution
**Overall Accountabilities from Site Identification to Close out:**
Ensure timely and accurate completion of project goals and update of applicable trial management systems.
+ Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
+ Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
+ Ensure that assigned sites are audit and inspection ready
+ Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
+ Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
+ Show commitment and perform consistent high-quality work.
+ Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
+ Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
+ Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
+ Provide input and feedback for Performance Development Conversation(s).
+ Proactively keep manager informed about work progress and any issues.
+ Develop expertise to become a subject matter expert.
+ Work in a self-driven capacity, with limited need for oversight.
+ Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
**Skills:**
+ Sound problem solving skills.
+ Able to take initiative and work independently, and to proactively seek guidance when necessary.
+ Advance presentation skills.
+ Client focused approach to work.
+ Ability to interact professionally within a client organization.
+ Flexible attitude with respect to work assignments and new learning.
+ Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
+ Willingness to work in a matrix environment and to value the importance of teamwork.
+ Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
+ Strong interpersonal, verbal, and written communication skills.
+ Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.
+ Effective time management in order to meet study needs, team objectives, and department goals.
+ Developing ability to work across cultures.
+ Shows commitment to and performs consistently high-quality work.
+ Ability to successfully work in a ('virtual') team environment.
+ Consulting Skills
+ Great attention to detail.
+ Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.
+ Holds a driver's license where required.
**Knowledge and Experience:**
+ Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
**Education:**
+ Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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