Sr. Medical Writer (Remote USA/Canada)
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.
Our Peripheral Intervention (PI) business unit offers a comprehensive range of medical products, devices and services for the treatment of peripheral arterial and venous disease, cancer detection, and end-stage renal disease and maintenance.
Provides mentoring/coaching of new hires and/or junior associates, where appropriate.
Manage and maintain project achievements and writing activities to align with business goals.
Coordinates with departments (e.g., Regulatory, R&D, Clinical Sciences, and Quality) to access and identify the necessary preclinical, clinical and technical information.
Coordinate external medical writing support/needs, as applicable.
Manage, prepare and update European and international Clinical Evaluation Reports (CERs) and summarize relevant literature for technical files/dossiers/registrations as required and per SOPs.
Manage internal NPD and consultant/ vendor relationships related to completion of clinical evaluation reports.
Ensure compliance to the applicable regulations and guidance documents.
Budget planning and budget management related to these activities.
Perform gap analyses and revise existing CERs for legacy products against the Medical Device Regulation ( EU MDR ).
Working with a multifunctional team, authors assigned protocols, final study reports, manuscripts for publication in peer-reviewed biomedical journals, meeting abstracts, internal reports, and presentations.
Generate and track timelines. Follows through on all tasks and ensures quality results.
May develop or revise templates, SOPs, or guidelines for regulatory/medical/clinical documents.
Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies.
Participates in post-market surveillance activities by leading routine detailed literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
Prioritizes and incorporates information, such as references, graphics, tables, and data listings for the creation of large, technical documents.
Independently, critically writes and edits scientifically complex documents for substantial intellectual content.
Maintains knowledge of current internal and external standards, regulations and technologies related to this function.
Prior project or program management experience.
Supervisory or team leader experience.
Must have excellent writing skills and the ability to communicate correctly and persuasively in English, and to use medical terminology accurately.
Requires in depth working knowledge of Microsoft Office Products and ability to manage multiple projects, interact with multi-disciplinary teams, and work independently with minimal supervision.
Ability to quickly acquire and apply understanding of therapeutic areas, medical device portfolios, business objectives, technical skills, clinical data/evidence.
Ability to use judgment based upon standards and polices and meeting timelines. Good problem-solving and analytical skills.
Anticipates problems, issues, and delays; proactively looks to minimize the impact to the project.
Ability to understand and interpret statistical results of clinical studies; specifically summarize sophisticated results and present them in accurate manner to various end users.
Understanding of regulatory and clinical requirements (e.g., European clinical requirements, including MEDDEV 2.7.1), along with writing CERs highly preferred.
Knowledge in narrative and detailed literature reviews required.
Creativity with interpretation and presentation of data an asset.
Excellent understanding of scientific or clinical research and methods required.
Establishes rapport and collaborates with team members; builds positive and effective relationships.
Education and/or Experience Required:
Bachelor’s degree (advanced degree preferred) in the sciences, a medical-related field, or medical/technical writing
Minimum of 5 years of experience writing CERs and Managing Clinical Programs and Resources.
Proficiency in MS Outlook, Word, Excel, and PowerPoint.
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.
To learn more about BD visit https://jobs.bd.com/
Becton, 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 AZ - Tempe Headquarters
Additional LocationsCAN Mississauga - Derry Road West, CAN Québec - Boulevard du Parc Technologique, USA CA - San Diego Bldg A&B, USA CA - San Jose, USA MD - Sparks - 39 Loveton Circle
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ