Medical Writer

TCS is hiring for Medical Writer!!!

Job Location – Mumbai / Pune / Bangalore

Experience Range – 3 to 15 Years

Educational Qualification(s) Required – Any Life Science Graduate

Roles & 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 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 o Ensure alignment and content re-use across documents for a product o Onboard lead document writers on document content alignment and timelines.