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Medical Writer

Tata Consultancy Services (Tcs)
TATA CONSULTANCY SERVICES (TCS)
3-6 years
upto 7 LPA
Mumbai, Pune, India
10 May 4, 2026
Job Description
Job Type: Full Time Education: B.Pharm, M.Pharm, Pharm D., BSc., MSc., Lifesciences graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Medical Writer Jobs in India 2026 | TCS Hiring Experienced Medical Writing Professionals | Mumbai & Pune

Company: Tata Consultancy Services
Job Role: Medical Writer
Job Type: Full-Time
Experience Required: 3–6 Years
Location: Mumbai, Pune
Application Deadline: 17 July 2026
Industry: Clinical Research | Medical Writing | Regulatory Affairs | Pharmaceutical Services
Job ID: 408771


About the Opportunity

Tata Consultancy Services is hiring experienced Medical Writing professionals for its Clinical and Regulatory Services team in Mumbai and Pune. This opportunity is ideal for candidates with strong expertise in clinical documentation, regulatory submissions, scientific writing, and cross-functional stakeholder coordination within the pharmaceutical and clinical research industry.

Professionals with hands-on experience in authoring and reviewing regulatory and clinical documents across multiple therapeutic areas are encouraged to apply.


Experience Required

  • Minimum Experience: 3 Years

  • Maximum Experience: 6 Years

  • Freshers are not eligible for this role


Educational Qualifications

Candidates with the following qualifications can apply:

  • Bachelor of Pharmacy (B.Pharm)

  • Master of Pharmacy (M.Pharm)

  • Bachelor of Science (B.Sc)

  • Master of Science (M.Sc)


Key Skills Required

  • Medical Writing

  • Clinical Documentation

  • Regulatory Writing

  • Clinical Study Reports (CSR)

  • Investigator’s Brochure (IB)

  • Clinical Study Protocols

  • Informed Consent Documents (ICD)

  • Pediatric Investigational Plans (PIP)

  • Clinical Overview & Clinical Summary Writing

  • CTD Structure Knowledge

  • ICH-GCP Guidelines

  • Scientific Review & Editing

  • Regulatory Submission Documentation

  • Stakeholder Coordination

  • MS Word, Excel, PowerPoint & Adobe Acrobat


Job Responsibilities

Clinical Document Authoring & Review

  • Author and edit scientific and clinical regulatory documents across multiple therapeutic areas

  • Prepare high-quality documentation for global regulatory submissions including US FDA, EMA, and other international agencies

  • Develop clinical study protocols, investigator brochures, clinical summaries, clinical overviews, informed consent documents, and clinical study reports

  • Ensure scientific accuracy, consistency, and compliance with regulatory standards

Regulatory & Compliance Management

  • Ensure adherence to ICH-GCP principles, CTD structure requirements, regulatory guidelines, templates, and internal SOPs

  • Conduct quality review of clinical documents within defined timelines

  • Maintain documentation quality standards aligned with global regulatory expectations

Project Coordination & Stakeholder Communication

  • Participate in project kick-off meetings and discuss documentation timelines and expectations

  • Collaborate effectively with cross-functional teams, reviewers, authors, regulatory experts, and key opinion leaders

  • Track project deliverables and provide updates on document progress

Documentation Leadership Responsibilities

  • Support document alignment and content consistency across regulatory submissions

  • Act as a primary point of contact for document preparation activities

  • Guide and mentor junior medical writers and newly onboarded team members

  • Participate in Regulatory Affairs and cross-functional team meetings

Continuous Learning & Industry Awareness

  • Stay updated with evolving regulatory guidelines, industry standards, scientific literature, and technological advancements in medical writing and clinical research


Preferred Candidate Profile

The ideal candidate should possess:

  • Strong analytical and scientific writing capabilities

  • Excellent written and verbal communication skills

  • Attention to detail and high-quality review expertise

  • Effective organizational and time management skills

  • Ability to manage multiple projects simultaneously

  • Strong interpersonal and presentation skills

  • Advanced proficiency in Microsoft Office tools and document management systems


Why Apply for This Medical Writer Role?

  • Opportunity to work with one of India’s leading global IT and life sciences organizations

  • Exposure to international regulatory documentation and submissions

  • Work on diverse therapeutic areas and global clinical projects

  • Career growth in medical writing, regulatory affairs, and clinical research operations

  • Collaborative work environment with experienced scientific and regulatory professionals


Job Location

  • Mumbai

  • Pune


Apply Now

Candidates with relevant experience in medical writing, clinical documentation, and regulatory affairs are encouraged to apply before the application deadline.

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