Medical Writing Sr Specialist
Job Description
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
Independently leads complex, high-risk clinical deliverables. Defines evidence strategies, develops robust benefit risk positions,
and provides expert review and mentorship to ensure high-quality, compliant documentation.
Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)
How You'll Create Impact
- Leads authorship of complex, high-risk post-market clinical deliverables such as Clinical Evaluation Reports (CERs) and
Summary of Safety and Clinical Performance (SSCP) - Defines and executes National Joint Registry (NJR) analysis as well as literature search strategies, appraisal criteria, and
evidence synthesis approaches - Interprets clinical and safety data to develop robust benefit–risk arguments
- Provides expert peer review of medical writing deliverables
- Mentors junior writers
- Partners with Clinical, Regulatory, and Development teams on evidence strategy
- Addresses autonomously Notified Body and regulatory questions related to clinical documentation
- Leads complex review cycles and issue resolution
- Contributes to improvements in templates, methodologies, and writing standards
- Functions as subject matter expert for medical writing aspects during Audit
What Makes You Stand Out
- Advanced scientific writing expertise
- Deep knowledge and independent ownership of Clinical Evaluation Plans (CEPs), CERs, Post-Market Surveillance (PMS),
- Post-Market Clinical Follow-up (PMCF), SSCP, and regulatory expectations
- Strong evidence evaluation and benefit–risk analysis capability
- Ability to mentor and provide expert-level review
- Strong stakeholder influence skills
- Problem-solving in regulatory and NB interactions
- Ability to manage complex, high-risk deliverables
- Commitment to high quality and continuous improvement
- Ability to efficiently prioritize multiple project tasks simultaneously, focusing on critical aspects while maintaining strategic oversight to deliver high-quality results and meet deadlines
- Ability to escalate and resolve compliance or risk concerns
Your Background
- Bachelor's Degree in Health, Life Sciences or related field and 4 years of relevant experience, or Associate's Degree and
- 6 years of relevant experience, or High School Diploma or Equivalent and 8 years of relevant experience
- Preferred: Degree in Health, Life Sciences or related field
- 4+ years medical or regulatory writing experience
- Experience in the clinical regulatory documentation within medical device industry is required.
- Responsible for authoring and discussing Systematic Literature Reviews and Clinical Evaluation Reports (CERs) for medical devices under Medical Device Regulation (MDR).
- Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Summary of Safety and Clinical Performance (SSCP) documents – extensive experience required.
- Very good English oral and written. Critical thinking and attention to detail.
EOE/M/F/Vet/Disability