Location: Mumbai / Pune, India
Company: Tata Consultancy Services
Job Function: Business Process Services (BPS)
Role: Executive
Job ID: 408771
Application Deadline: 17 July 2026
Experience Required: 3–6 Years (Not suitable for freshers)
About the Role
Tata Consultancy Services is actively hiring experienced Medical Writers to support global clinical and regulatory documentation projects. This role is ideal for professionals with strong expertise in scientific writing, clinical research documentation, and regulatory submission processes across international markets including the US and Europe.
Key Responsibilities
Lead authoring and editing of clinical and regulatory documents including Clinical Study Protocols, Clinical Study Reports (CSR), Investigator’s Brochure (IB), Informed Consent Forms (ICF), Pediatric Investigational Plans (PIP), Clinical Overviews (efficacy and safety), and Briefing Packages
Ensure high-quality documentation aligned with ICH-GCP guidelines, regulatory standards, and internal SOPs
Perform detailed scientific review, data interpretation, and quality checks within defined timelines
Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Key Opinion Leaders (KOLs)
Manage document timelines, project expectations, and stakeholder communication effectively
Stay updated with evolving regulatory guidelines, industry trends, and therapeutic area knowledge
Mentor and train junior medical writers and oversee their project deliverables
Act as Documentation Lead when required, ensuring consistency, alignment, and content reuse across documents
Participate in regulatory and cross-functional meetings to support submission readiness
Required Skills and Competencies
Strong expertise in medical writing across multiple therapeutic areas
In-depth knowledge of clinical research processes, ICH-GCP guidelines, and Common Technical Document (CTD) structure
Excellent scientific writing, editing, and analytical skills
Ability to present complex clinical data in a clear, concise, and structured manner
Strong communication, coordination, and stakeholder management abilities
Proficiency in MS Word, PowerPoint, Excel, and Adobe Acrobat
Educational Qualifications
Bachelor of Pharmacy (B.Pharm)
Master of Pharmacy (M.Pharm)
Bachelor of Science (B.Sc)
Master of Science (M.Sc)
Work Environment & Reporting Structure
Reporting to Team Lead / Group Lead
Exposure to global clinical documentation and regulatory submission projects
Opportunity to work in a structured, process-driven, and high-impact environment
Important Note for Applicants
This position requires prior experience in medical writing and clinical documentation. Candidates without relevant industry experience are advised to explore entry-level roles such as Drug Safety Associate, Clinical Data Management Associate, or Junior Medical Writer roles before applying.
How to Apply
Apply before the deadline through official career portals. For verified and regularly updated global pharmaceutical job opportunities, visit ThePharmaDaily.com
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