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Senior Medical Writer

Navitas Lifesciences
Navitas lifesciences
5+ years
preferred by company
Bangalore, India
1 May 18, 2026
Job Description
Job Type: Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

Senior Medical Writer

Location: Bengaluru, India
Job Type: Full-Time
Work Mode: Onsite / Hybrid (As Per Business Requirement)
Industry: Clinical Research | Medical Writing | Regulatory Affairs | Pharmaceutical | Life Sciences
Department: Clinical Research / Regulatory Medical Writing
Experience Required: Minimum 5+ Years (Freshers Not Eligible)
Employment Level: Associate / Senior-Level Professional

Job Overview

A growing clinical research organization is seeking an experienced Senior Medical Writer to join its expanding clinical and regulatory team in Bengaluru. This opportunity is ideal for highly skilled professionals with expertise in regulatory medical writing, clinical documentation, CTD dossier preparation, protocol writing, clinical study reports, IND/NDA submissions, and scientific communication.

The selected candidate will be responsible for developing, reviewing, and managing complex regulatory and clinical research documents for global submissions while ensuring compliance with international regulatory standards and sponsor expectations.

This role is ideal for professionals looking to advance their careers in medical writing, regulatory affairs, clinical documentation, and pharmaceutical scientific communications.

Key Responsibilities

Clinical & Regulatory Medical Writing

Develop, draft, review, and manage high-quality regulatory and clinical documents including:

  • Clinical Study Protocols
  • Clinical Study Outlines
  • Feasibility Synopses
  • Clinical Study Reports (CSRs)
  • Informed Consent Documents (ICD / ICF)
  • Investigator Brochures (IB)
  • Subject Diaries
  • SAE Narratives
  • Study-Specific Documentation
  • Regulatory Submission Documentation

Support documentation for:

  • Phase I Clinical Trials
  • Phase II Clinical Trials
  • Phase III Clinical Trials
  • Phase IV Clinical Trials
  • Bioavailability (BA) Studies
  • Bioequivalence (BE) Studies

Regulatory Submission Documentation

Prepare and review regulatory writing deliverables for global submissions including:

  • Common Technical Document (CTD)
  • Module 2.4 – Non-Clinical Overview
  • Module 2.5 – Clinical Overview
  • Module 2.6 Documentation
  • Module 2.7 Summaries
  • Integrated Summary of Safety (ISS)
  • Integrated Summary of Efficacy (ISE)

Support submissions for:

  • IND (Investigational New Drug)
  • NDA (New Drug Application)
  • BLA (Biologics License Application)
  • MAA (Marketing Authorization Application)
  • 505(b)(2) Applications
  • Biosimilar Submissions
  • Hybrid Applications

Regulatory Strategy Documentation

Develop and support strategic regulatory documentation including:

  • Pre-IND briefing packages
  • Pre-NDA briefing documents
  • Scientific Advisory Meeting (SAM) briefing packages
  • Orphan Drug Designation feasibility reports
  • Expedited approval documentation
  • Regulatory authority submission support packages

Cross-Functional Clinical Documentation Support

Collaborate with internal teams to support:

  • Statistical Analysis Plans (SAP)
  • Mock TLFs
  • eCRF outlines
  • Study-specific scientific documentation
  • Clinical trial operational documents

Work closely with:

  • Biostatistics
  • Data Management
  • Regulatory Affairs
  • Clinical Operations
  • Medical Leads
  • Project Teams

Medical Writing Quality & Compliance

  • Perform technical review and quality control of regulatory medical writing deliverables.
  • Ensure all documentation complies with:
    • ICH guidelines
    • Global regulatory standards
    • Internal SOPs
    • Sponsor/client expectations
  • Support departmental SOP preparation and process improvements.
  • Maintain accuracy, scientific consistency, and document quality.

Project & Stakeholder Management

  • Independently manage medical writing deliverables across multiple projects.
  • Coordinate timelines, document reviews, and stakeholder communications.
  • Participate in internal and client-facing discussions.
  • Understand client expectations and ensure timely, high-quality deliverables.

Administrative & Departmental Support

  • Support medical writing department operations and documentation processes.
  • Handle additional responsibilities assigned by department leadership.

Educational Qualification

Candidates should possess one of the following:

  • PhD (Medical / Life Sciences / Pharmaceutical Sciences)
  • MBBS
  • MD
  • M.Pharm
  • Pharm.D

Preferred backgrounds:

  • Clinical Research
  • Pharmacology
  • Regulatory Affairs
  • Medical Sciences
  • Pharmaceutical Sciences