Medical Writer

Job Description

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. Show more Show less