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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.
This is a two-year position with an opportunity for a permanent role.
The Medical Writer will possess an understanding of regulatory requirements for clinical evaluation plans (CEPs) and clinical evaluation reports (CERs) to support BD product registration efforts on the EU market. The candidate will lead CEP and CER writing activities and will work closely with other departments and functions to ensure the development of high quality documents in alignment with project timelines and priorities.
Essential / Key Job Responsibilities:
Prepare and update European and international Clinical Evaluation Reports (CERs) and summarize relevant literature for technical files/dossiers/registrations as required and per applicable SOPs. Ensure compliance to the applicable regulations and guidance documents.
Coordinates with various departments (e.g., Regulatory, R&D, Clinical Affairs, and Quality) to access and identify the necessary preclinical, clinical and technical information.
Perform gap analyses and revise existing CERs for legacy products against the Medical Device Regulation.
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 systematic 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.
Organizes 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.
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 complex results and present them in clear, concise, and scientifically accurate manner to various end users.
Knowledge in narrative and systematic 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 other (internal and external) team members; builds constructive and effective relationships.
Experience writing CERs highly preferred.
Understanding of current regulatory and clinical requirements (e.g., European clinical requirements, including MEDDEV 2.7.1), highly preferred.
Education and/or Experience:
Bachelor’s degree (advanced degree preferred) in the sciences, a medical-related field, or medical/technical writing.
Minimum of 1-3 years of medical device experience.
For 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 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.
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