BD (Becton, Dickinson and Company) Senior Medical Writer / Clinical Affairs Specialist in Wexford, Ireland
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
At the Enniscorthy facility, we design, develop and manufacture angioplasty catheters that are used in the treatment of peripheral artery disease. Our minimally invasive product portfolio offers an extensive range of CE Marked & FDA approved PTA and Stent Delivery Systems. We are now recruiting for an experienced regulatory & medical writer (Permanent Role).
About the role
As a Medical Writer / Clinical Affairs Specialist , you will be reporting to the Associate Director Clinical Affairs and will be responsible for the execution of clinical and PMCF studies while working with a cross-functional team in accordance with the highest quality standards. You will liaise with external service providers and manage sites for national & international clinical studies. You will prepare clinical documentation for regulatory submissions.
Main responsibilities will include:
Writing and maintaining of documents required for EU MDR submissions, such as Clinical Evaluation Plans and Reports, Post-market Clinical Follow Plans and Reports in compliance with applicable regulatory requirements (EU MDR, MEDDEV 2.7/1, MDCG);
Writing and compilation of documents for regulatory submission during all phases of clinical development and the post-marketing period, such as EC Submissions, Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Periodic Benefit-Risk Evaluation Reports;
Provide comprehensive responses to clinical questions raised by regulatory body file reviews (e.g. Notified Body, FDA, etc.);
Support of new product development activities (e.g. development of clinical strategies) applying problem-solving skills to any issues with cross-functional study team;
Project management and organization of external service providers (e.g. CROs);
Support international clinical studies as needed (up to 10% travel within Europe);
Write study protocols, safety plans and reports;
Support international product registrations and regulatory audits.
The ideal candidate will have previous experience in clinical evaluations or HTA working in cross-functional teams in the Medical Device/Pharmaceutical industry, or in a similar setting related to medicine or LifeSciences. You will have a clear, concise scientific style of writing. As a result of this experience, the candidate will be able to successfully:
Write each of the above-named document types with minimal supervision
Review each of these document types and provide input for improvement
Conduct scientific literature searches and data analyses, interpreting & summarising the data
You will hold an academic degree in a relevant field (Master of Science or higher graduate degree). Ideally you will have proficiency in literature database searches. Basic knowledge of biostatistics and medical background/application of BD products.
You will have attention to detail to provide high-quality results. Proactive personality and willingness to develop in a global company.
Click on apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, or any other protected status.
To learn more about BD visit https://emea.jobs.bd.com/
Primary Work Location
IRL Wexford - Enniscorthy
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.