Job Description

Job Description

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.

Responsibilities:

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 (CER).

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.

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.

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.

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.

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.

Education and/or Experience Required:

Bachelor’s degree (advanced degree preferred) in the sciences, a medical-related field, or medical/technical writing.

Must have excellent writing skills and the ability to communicate correctly and persuasively in English, and to use medical terminology accurately.

Minimum of 5 years of experience writing clinical evaluation plans and clinical evaluation reports (CEP/CER).