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Manager - Medical Writing

Elanco
3+ years
INR 18 LPA – 32 LPA
Bangalore, India
1 June 23, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: CPT, HCPCS Level II, ICD-10-CM, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICD-10-PCS, Medical Billing, Medical Coding

Manager – Medical Writing

Location: Bangalore, India
Company: Elanco
Department: Global R&D / Regulatory Affairs
Employment Type: Full-Time

Role Summary

The Manager – Medical Writing is responsible for authoring, reviewing, and managing high-quality scientific, regulatory, and clinical documents that support product development, regulatory submissions, and scientific communication activities. The role involves preparing study protocols, final study reports, manuscripts, review articles, abstracts, posters, slide decks, and regulatory documentation while ensuring compliance with global regulatory requirements and scientific standards.

This position serves as a Medical Writing Lead for assigned programs and collaborates closely with Regulatory Affairs, Global R&D, and cross-functional teams to deliver scientifically accurate, publication-ready, and regulatory-compliant documentation.

Key Responsibilities

Regulatory & Scientific Writing

  • Author and review:

    • Study Protocols

    • Final Study Reports (FSRs)

    • Clinical Study Reports (CSRs)

    • Summary Reports

    • Regulatory Documents

  • Ensure compliance with:

    • VICH GL9 Guidelines

    • OECD Principles

    • FDA Regulations

    • EMA Regulations

    • Global Regulatory Requirements

  • Develop document strategies for assigned projects.

Scientific Publications & Communication

  • Prepare and review:

    • Manuscripts

    • Review Articles

    • Scientific Abstracts

    • Posters

    • Slide Presentations

    • Scientific Publications

  • Support publication planning and scientific communication activities.

  • Ensure scientific consistency and data accuracy.

Data Interpretation & Analysis

  • Interpret:

    • Safety Data

    • Efficacy Data

    • Pharmacokinetic Data

    • Clinical Research Data

  • Translate scientific findings into clear, concise documentation.

  • Collaborate with subject matter experts for scientific accuracy.

Literature Review & Evidence Generation

  • Conduct literature searches and evidence reviews.

  • Prepare literature summaries and scientific reports.

  • Support regulatory and scientific decision-making through evidence analysis.

Quality Control & Compliance

  • Perform proofreading and QC review of documents.

  • Ensure compliance with:

    • Good Documentation Practices (GDP)

    • SOPs

    • Regulatory Writing Standards

  • Maintain audit readiness and training compliance.

  • Ensure document accuracy, consistency, and completeness.

Project Management & Leadership

  • Serve as Medical Writing Lead for assigned projects.

  • Manage multiple writing projects simultaneously.

  • Track timelines, milestones, and deliverables.

  • Coordinate stakeholder reviews and approvals.

  • Identify document preparation strategies proactively.

Cross-Functional Collaboration

  • Collaborate with:

    • Regulatory Affairs

    • Global R&D Teams

    • Clinical Research Teams

    • Scientific Experts

    • Global Stakeholders

  • Gather feedback and implement customer requirements.

  • Support product development and registration activities.

Documentation Management

  • Maintain project documentation in controlled repositories.

  • Ensure proper version control and document tracking.

  • Maintain audit, SOP, and training records.

Required Qualifications

Education

One of the following:

  • PhD in:

    • Veterinary Medicine

    • Pharmacology

    • Biotechnology

    • Biochemistry

    • Microbiology

    • Life Sciences

OR

  • Master’s Degree in:

    • Life Sciences

    • Biotechnology

    • Pharmacology

    • Veterinary Sciences

    • Related Scientific Discipline

Experience

  • PhD with 3+ years of relevant experience

OR

  • Master’s Degree with 5+ years of relevant experience

  • 3–5+ years of Medical Writing experience.

  • Experience authoring:

    • Clinical Study Reports

    • Study Protocols

    • Regulatory Documents

    • Scientific Publications

  • Publications in peer-reviewed journals preferred.

  • Experience working with global stakeholders.