TCS is Hiring Medical Writer professionals

Experience - 3 to 6 years

Location: Mumbai, Pune

Job Description:
- Overall 3 years’ of authoring/editing experience in medical writing domain across

different therapeutic areas in clinical documents including clinical study protocol,

pediatric investigational plan, informed consent document, clinical study report,

investigator’s brochure, clinical summary of pharmacology, clinical overview (efficacy

and safety), briefing package/pre-meeting package preferred
- Experience in preparation of clinical documents necessary for national and international

regulatory submissions to the US, European and other regulatory agencies
- Clear, concise and scientific style of writing, with attention to detail
- Strong analytical skills and expertise in writing and review of scientific/clinical

documents
- Valuable knowledge of clinical research domain, ICH GCP principles, Common

Technical Document (CTD) structure and regulatory requirements
- Effective coordination and presentation skills - good organization and time management skills




- Exceptional interpersonal, verbal and written communication skills
- Computer Literate: Knowledge of MS Word, PowerPoint, Adobe Acrobat, MS Excel, etc.

Reporting to (Role): Team Lead/Group Lead

Responsibilities:
- Setting, discussing and meeting expectations of the document during kick off and

subsequent meetings
- Lead the authoring/editing of clinical documents, as mentioned above.
- Ensure adherence to established processes, timelines, regulatory guidelines and applicable

standards, styles, guidelines
- Perform quality review of the clinical documents within established timelines with

adherence to applicable guidelines, templates, and processes
- Ability to effectively and proactively communicate with internal and external stakeholders,

including authors and key opinion leaders as appropriate (including problem-solving and

resolution of issues)
- Keep abreast of project status, clinical oper

📌 Medical Writer (Mumbai)
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