Job Opportunity: Medical Writer (Clinical Affairs) – BD
Job Summary
BD (Becton Dickinson), a global leader in medical technology, is seeking a skilled and detail-oriented Medical Writer to join our Interventional Surgery Business Unit. This is a remote-based role in India, specifically designed for professionals with expertise in medical device regulatory documentation. In this position, you will play a vital role in clinical strategy and global submissions by preparing high-quality clinical evaluation reports and supporting our ongoing compliance with international regulatory standards. This is an excellent opportunity to advance your career within a prestigious, innovation-driven organization.
Responsibilities
As a Medical Writer at BD, you will be responsible for the end-to-end documentation process required for global regulatory submissions. Your primary duties will include:
- Documentation Development: Prepare, review, and maintain Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for diverse medical device portfolios.
- Data Analysis: Conduct comprehensive systematic literature reviews using databases such as PubMed, Embase, and Ovid. You will analyze complex clinical data, real-world evidence, and clinical trial results to support regulatory claims.
- Regulatory Compliance: Ensure all documentation adheres strictly to MEDDEV 2.7/1 Rev 4, MDCG, IMDRF guidelines, and current EU MDR requirements.
- Cross-Functional Collaboration: Partner closely with internal teams, including Regulatory Affairs, Product Development, Quality, and Post-Market Surveillance (PMS), to align on clinical strategy.
- Post-Market Support: Contribute to the creation of post-market surveillance reports and safety documentation to ensure long-term product efficacy and compliance.
Requirements
To be successful in this role, you should possess a strong background in scientific writing and a deep understanding of the medical device landscape:
- Education: A Bachelor’s degree in Life Sciences, Pharmacy, or a medical-related field is required. An advanced degree (M.Pharm, MSc, MPH, or PhD) is highly preferred.
- Experience: 2–4 years of proven experience in medical writing, with a specific focus on medical devices. You must have demonstrated experience in end-to-end CER writing.
- Regulatory Knowledge: Solid understanding of EU MDR and clinical evaluation frameworks. Exposure to Class II and Class III medical devices is essential.
- Technical Skills:
- Expertise in literature search and systematic review methodologies.
- Proficiency in MS Office Suite (Word, Excel, PowerPoint).
- Familiarity with tools such as DistillerSR is highly preferred.
- Communication: Exceptional English writing, editing, and proofreading skills.
- Soft Skills: Proven ability to manage multiple regulatory projects simultaneously while maintaining high standards of accuracy and attention to detail.
Benefits
BD offers a dynamic and supportive work environment that values professional development and innovation:
- Flexible Work Environment: Enjoy the benefits of a remote-first role.
- Competitive Compensation: An estimated salary range of ₹8 LPA – ₹14 LPA, commensurate with your experience and qualifications.
- Professional Growth: Gain significant global exposure in medical device regulatory writing and work on high-risk, high-impact submissions.
- Career Advancement: Opportunities to build a long-term career in clinical affairs and regulatory strategy within one of the world’s leading medical technology companies.
How to Apply
We invite qualified candidates who are ready to make an impact to apply for this position. Please visit the official BD Careers portal using the link below to submit your application and view the full job description (Job ID: R-539573):
Submit Application via BD Official Careers Portal
BD is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.