Manager – Medical Writing
Company: Elanco
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Department: Medical Writing / Global R&D
Experience: 3–5+ Years Medical Writing Experience
About the Role
Elanco is seeking a Manager – Medical Writing to support the preparation of high-quality regulatory and scientific documents for global research and development programs. The role involves developing study protocols, final study reports, manuscripts, scientific publications, and regulatory documentation while collaborating with Regulatory Affairs, Global R&D teams, and cross-functional stakeholders.
The successful candidate will serve as a medical writing lead on assigned projects and contribute to the development of scientifically accurate, compliant, and submission-ready documents.
Key Responsibilities
Medical Writing & Regulatory Documentation
Prepare and author:
Study Protocols
Final Study Reports (FSRs)
Summary Reports
Regulatory Documents
Scientific Publications
Ensure compliance with VICH GL9, OECD Principles, EMA, FDA, and other applicable regulatory guidelines.
Develop clear, scientifically accurate, and high-quality documentation.
Scientific Publications & Communications
Draft and review:
Manuscripts
Review Articles
Abstracts
Posters
Scientific Presentations
Slide Decks
Support publication and scientific communication strategies.
Data Analysis & Literature Review
Interpret safety, efficacy, and pharmacokinetic study data.
Conduct literature searches and scientific evidence reviews.
Prepare scientific summaries and supporting documentation.
Project Leadership
Serve as Medical Writing Lead for assigned projects and programs.
Develop document preparation strategies and timelines.
Manage multiple projects simultaneously while ensuring milestone completion.
Coordinate with Regulatory Affairs, R&D teams, and global stakeholders.
Quality & Compliance
Perform proofreading and quality control (QC) reviews.
Ensure compliance with Good Documentation Practices (GDP).
Maintain audit readiness and training compliance.
Manage project documentation within controlled systems and repositories.
Required Qualifications
Education
PhD in Life Sciences, Veterinary Medicine, Biochemistry, Microbiology, Biotechnology, Pharmacology, or related discipline
OR
Master's Degree in Life Sciences with relevant industry experience.
Experience
PhD with 3+ years of relevant experience
OR
Master's Degree with 5+ years of relevant experience.
Proven experience in Medical Writing, Scientific Writing, or R&D Documentation.
Experience authoring Clinical/Non-Clinical Study Reports and Scientific Publications.
Experience working with global cross-functional teams.
Uttar Pradesh :
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