Medical Writing Sr Specialist

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)

 Leads authorship of complex, high-risk post-market clinical deliverables such as Clinical Evaluation Reports (CERs) & 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

 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

Bachelor's Degree in Health, Life Sciences or related field and 4 years of relevant experience, or Associate's Degree & 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

Up to 5%

EOE/M/F/Vet/Disability