Medical Writing

4 days ago

Mumbai Maharashtra, India Tata Consultancy Services Full time

TCS is hiring for **Medical Writing Role**
- 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 operating plans and ongoing/new studies as well as scientific literature within assigned project
- Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards
- Training and mentoring of the new recruits/existing medical writers
- Oversee live projects assigned to the new medical writers and guide them as required
- As required, take on functional role and responsibilities of the role of Documentation Lead -o Lead PDRD deliverables for project and act as first point of contact for any information that is required for content/document preparation
- Ensure alignment and content re-use across documents for a product
- Onboard lead document writers on document content alignment and timelines.
- Provide required source documents incl. information pertaining to study documentation, relevant project contacts (authors, reviewers), developmental strategy
- Actively participate in Regulatory Affairs Functional or other cross functional team meetings
- Review content of document prior to finalization to ensure high quality prior to initiation of author review or Expert Team Review

Qualifications :BACHELOR OF PHARMACY, BACHELOR OF SCIENCE (B.Sc), M.SC., MASTER OF SCIENCE, MASTER OF SCIENCE (APPLIED PHYSICS)

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