Are you a skilled Medical Writer looking for an exciting opportunity with a leading global IT and consulting firm? Tata Consultancy Services (TCS) is currently hiring Medical Writers for their Mumbai and Pune locations. If you have 3 to 7 years of experience in clinical documentation and regulatory submissions, this could be your next career move!
Job Details
- Position: Medical Writer
- Location: Mumbai, Maharashtra / Pune, India
- Experience: 3 to 7 years
Key Responsibilities
As a Medical Writer at TCS, your primary responsibilities will include:
- Authoring and editing clinical documents such as:
- Clinical Study Protocols
- Pediatric Investigation Plans (PIP)
- Informed Consent Documents (ICD)
- Clinical Study Reports (CSR)
- Investigator’s Brochures (IB)
- Clinical Summaries (Efficacy & Safety)
- Briefing Packages for Regulatory Submissions
- Ensuring compliance with ICH-GCP, CTD structure, and global regulatory guidelines (US FDA, EMA, etc.).
- Performing quality reviews of clinical documents.
- Collaborating with internal and external stakeholders, including authors and key opinion leaders (KOLs).
- Training and mentoring junior medical writers.
- Leading documentation projects and ensuring alignment across regulatory submissions.
Required Skills & Qualifications
To be eligible for this role, candidates should possess:
- 3+ years of experience in medical writing for clinical/regulatory documents.
- Strong knowledge of clinical research, ICH-GCP, and regulatory submission processes.
- Excellent scientific writing, editing, and analytical skills.
- Proficiency in MS Word, PowerPoint, Excel, and Adobe Acrobat.
- Strong communication, coordination, and time-management skills.
- Ability to train and guide junior writers.
Why Join TCS?
- Work with a globally recognized IT & consulting leader.
- Opportunity to contribute to high-impact clinical and regulatory projects.
- Career growth and skill development in medical writing and regulatory affairs.
- Collaborative work environment with industry experts.
