Medical Writer

Description

We are the makers of possible

BD 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 Summary :

The Medical Writer willpossessan understanding of regulatory requirements for clinical evaluation, post-market clinical follow-up (PMCF) documentation,and relateddeliverables. In this role,the Medical Writerdevelopshigh-quality documentsthatensure clarity, accuracy, and compliance with applicable standardswhile meetingproject timelines and priorities.

The ideal candidatedemonstratesexceptionalwriting skills,communicatesclearlyand persuasively in English,and usesmedical terminology accurately.Therole requiresstrongattention to detailand theability toidentifyinconsistencies, gaps, and errors in complex technical content.Strong organizational skills,projectmanagement,effectivecollaboration, and independentworkwith minimal supervisionare essential.

Success also requires theability to quicklyacquireand applyknowledgeof therapeutic areas, medical device portfolios, businessobjectives, technicalconcepts,andclinical evidence. The Medical Writer must exercise soundjudgment based on standards and policies,managedeadlineseffectively, and apply stronganalytical andproblem-solving skills.Anticipatingissues,addressing potentialdelays,and minimizing impactsonproject timelines areessential forhigh performancein this role.

Responsibilities :

Prepare and updateEUClinical Evaluation Reports (CERs) and summarize relevant literatureto supporttechnical files,dossiers,registrations,and other regulatory documentationin accordance withapplicable SOPs,regulations,and guidance documents.

Coordinate withavariety of cross-functional partners(e.g., Regulatory, R&D, Clinical Affairs, and Quality) to access andidentifynecessary preclinical, clinical,and technical information.

Generate and track timelines,follow through ontasksand ensurehigh-quality results.

Develop or revise templates, SOPs, or guidelines for regulatory, medical, or clinicaldocumentation.

Conduct scientific literature reviews and compile reports, includingliterature updates and periodic safety updates.

Lead routine systematic literature reviewsfor specific medical device groups or sub-groups, including screening articles against eligibility criteria, extracting data from included studies, interpreting results, and synthesizing the data into formal reports.

Organize and incorporate references, graphics, tables, and data for the creation of large, technical documents.

Write and edit scientifically complex documents for substantial intellectual content.

Maintain knowledge of internal and external standards, regulations,and technologies.

MinimumRequirements :

Bachelor’s degree in the sciences,medical-related field, or medical / technical writingand1-3years of medical device experience ORat least5years of medical device experience.

Experience or understanding of scientific or clinical research and methods.

Working knowledge of Microsoft Office Products.

Ability to interpret statistical results of clinical studiesandsummarizefindingsclearly and accurately.

Ability tocollaborateeffectivelywithMedical Writing team members andcross-functional stakeholders.

PreferredSkills / Experience :

Advanced degree in the sciences,medical-related field, or medical / technical writing.

Experience writing CEPs, CERs, and PMCF Plans and Reports.

Understanding of current regulatory and clinical requirements (e.g., EU-MDR)

Knowledge in narrative and systematic literature reviews; accuracy with interpretation and presentation of data.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 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.