Senior Medical Writer

Job Description SummaryMedical Affairs Senior Medical Writer will be responsible for the evaluation of clinical data and in the writing/creation of clinical evaluation plans and reports. These documents are used in regulatory submissions to support safety and performance of our products, to help define clinical endpoints for currently marketed devices and New Product Development Teams, and to aid in the identification of new risks, indications and unmet needs. This role will support the BD Medication Delivery Systems Unit - Medical Affairs Function. This individual will report to the Associate Director, Medical Affairs within this team. If you would like to part of a talented and dynamic team and love working on challenging projects, come join the BD family!Job DescriptionWe are the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.Job DescriptionThe Medical Affairs Senior Medical Writer will combine their knowledge of science with their understanding of research and writing to present information effectively and clearly. The Senior Medical Writer will focus on scientific medical writing to prepare documents for regulatory submissions to support safety and performance of our products, to help define clinical endpoints for currently marketed devices and New Product Development Teams, and to aid in the identification of new risks, indications and unmet needs. The Senior Medical writer will interface with other functions as necessary to ensure accurate and timely completion and review of documents for clinical regulatory submissions. The Senior Medical Writer will be expected to conduct comprehensive literature searches, to read and understand relevant literature, and to synthesize and summarize the relevant literature regarding subject medical devices. The Senior Medical Writer will be responsible for the evaluation of clinical data and in the writing/creation of clinical evaluation plans and reports.Education & Experience• Minimum of a Bachelor’s Degree required. Advanced degree strongly preferred.• Medical background (e.g., RN, MD / DO, PharmD), or PhD strongly preferred.• Relevant medical device experience writing Clinical Evaluation Plans / Reports (a minimum of 5 years experience strongly preferred)• Scientific writing experience with experience conducting systematic literature searches required (a minimum of 5 years experience strongly preferred).• Certification through the American Medical Writing Association (AMWA) preferredSkills• Ability to write with scientific accuracy and to compile, write, edit and format documents for submission to regulatory agencies• Experience in conducting literature searches required• Ability to develop and conduct comprehensive literature searches i.e., interpret / summarize / synthesize relevant literature)• Understanding of MEDDEV 2.7/1 rev4 guidelines, Health Canada, and the EU MDR regulations related to clinical evaluation reports• Ability to ensure that all deliverables are in accordance with applicable regulations, standards, and guidelines• Excellent written and verbal communication skills• Superior attention to detail• Proficiency in Microsoft Word• Proficiency in Excel• Excellent time management skills, and ability to meet deadlines• Working knowledge of statistical concepts and techniques• Ability to work collaboratively with cross-functional teams• Ability to function well both individually and as part of a team• Participate in Query Support• Provide / Coordinate query input across medical writing team related to literature search and/or clinical data• Ensure responses are incorporated into the CEP and CER• Participate in meetings with the notified body, query review, resource assignment, and timeline estimatesFor certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.To learn more about BD visit https://bd.com/careersBecton, Dickinson and Company is an Equal Opportunity/Affirmative Action 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, military eligibility or veteran status, or any other protected status.Primary Work LocationUSA NJ - Franklin LakesAdditional LocationsWork Shift