Medical Writing Specialist

Zimmer Biomet

Bengaluru

Hybrid

INR 1,200,000 - 1,800,000

Full time

3 days ago
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Benefits offered by this job

Hybrid work model (3 days in office)

Job summary

Zimmer Biomet in Bangalore is seeking a regulatory clinical documentation writer to independently author standard sections of CEPs, CERs, PMS, PMCF, and SSCP, delivering audit-ready documentation in collaboration with cross-functional teams.

The role includes executing NJR analysis and literature search strategies, drafting clinical safety and performance summaries, and ensuring traceability across sources to meet global regulatory obligations. Hybrid work arrangement applies.

Qualifications

  • Strong scientific and technical writing skills.
  • Basic working knowledge of medical device clinical and regulatory documentation.
  • Ability to execute literature strategies and appraise evidence.
  • Ability to analyze National Joint Registry (NJR) data.
  • Understanding of global medical device regulations and post-market obligations.
  • Strong analytical and data synthesis skills.

Responsibilities

  • Author sections of CEPs, CERs, PMS, PMCF, and SSCP documents.
  • Executes NJR analysis and literature search strategies.
  • Drafts clinical safety and performance summaries and benefit–risk analyses.
  • Ensures traceability across data sources and regulatory requirements.
  • Maintains template compliance and audit-ready documentation.
  • Coordinates with Regulatory, Clinical, and Development partners to finalize drafts.
  • Supports methodological consistency across product lines.
  • Participates in internal peer reviews.
  • Manages timelines for assigned deliverables.
  • Follows established procedures.
  • Performs quality control checks for formatting, references, and traceability.

Skills

Scientific writing
Technical writing
Literature strategies
NJR data analysis
Regulatory knowledge
Data synthesis

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.

What You Can Expect

Independently authors standard sections of regulatory clinical documents with limited supervision. Executes literature
strategies, execute National Joint Registry (NJR) data analysis, ensures traceability and compliance, and collaborates crossfunctionally
to deliver audit-ready documentation.
Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)

How You'll Create Impact
  • Independently authors standard sections of 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
  • Executes NJR analysis and literature search strategies and documents appraisal outcomes
  • Drafts clinical safety and performance summaries and benefit–risk analyses
  • Ensures traceability across data sources and regulatory requirements
  • Maintains template compliance and audit-ready documentation
  • Coordinates with Regulatory, Clinical, and Development partners to finalize drafts
  • Supports methodological consistency across product lines
  • Participates in internal peer reviews
  • Manages timelines for assigned deliverables
  • Follows established procedures
  • Performs quality control checks for formatting, references, and traceability
  • Ability to escal… risk concerns
What Makes You Stand Out
  • Strong scientific and technical writing skills
  • Basic working knowledge of medical device clinical and regulatory documentation
  • Ability to execute literature strategies and appraise evidence
  • Ability to analyze National Joint Registry (NJR) data
  • Understanding of global medical device regulations and post-market obligations
  • Strong analytical and data synthesis skills
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