Medical Sr Writer

Role & Responsibilities
• Independently identify internal and external clinical data sources and conduct systematic literature searches of peer-reviewed publications
• Prepare Clinical Evaluation documentation in line with EU guidance and Zimmer Biomet internal procedures using clinical research, peer-reviewed literature, risk management files, and post-market data
• Manage Clinical Evaluation Report (CER) and Post-Market Surveillance (PMS) activities across the clinical team, including planning, tracking, and delivery
• Summarize findings and write risk–benefit analyses, conclusions, and clinical justifications based on compiled evidence
• Support development of related documents such as study protocols, investigational plans, manuscripts for publication, and internal white papers as required
• Collaborate with Clinical Affairs, Regulatory Affairs, Post-Market Surveillance, Risk Management, and Development Engineering to verify content and obtain approvals for final documentation
• Prepare peer-reviewed literature reviews for inclusion in PMS documentation and maintain Clinical Evaluation archives
• Provide clinical data searches and documentation support to multiple functions across the organization
• Manage writing, review, maintenance, and publishing of controlled documentation as per regulatory requirements
• Design and execute literature and registry searches using relevant keywords and document search methodology and outputs

Qualification
• Bachelor’s degree in health sciences, life sciences, engineering, or a similar discipline

Experience
• 5+ years of professional experience in clinical investigation, medical writing, systematic literature review, and clinical data appraisal
• Proven experience developing CER, SSCP, and PSUR in compliance with MEDDEV 2.7.1 Rev 4 and EU MDR 2017/745
• Experience in clinical, regulatory, or product engineering roles within the medical device industry
• Orthopedic medical device sector experience preferred

Skills
• Clinical, regulatory, and technical writing for medical devices (CER, SSCP, PSUR)
• Systematic literature review design, execution, and documentation
• Strong risk–benefit writing and clinical data interpretation
• Knowledge of EU medical device regulations (EU MDR 2017/745, MEDDEV 2.7.1 Rev 4)
• Understanding of clinical research methodology and statistical concepts
• Strong bibliographic research, editorial, proofreading, and attention to detail skills
• Project management and cross-functional stakeholder coordination
• Proficiency with MS Office and reference management/bibliography tools
• Knowledge of ethical publication standards (AMWA/EMWA) and regulatory compliance expectations

About The Company
Zimmer Biomet is a global medical technology leader with nearly 100 years of innovation, focused on enhancing patient mobility and improving quality of life worldwide. The company offers a collaborative culture, development opportunities, employee resource groups, wellness initiatives, and competitive total rewards, with this hybrid role based in Bangalore (3 days in office).