Job Title

TCS is hiring forMedical WriterRole!!!Location:Mumbai/PuneExperience:3 to 7 yearsPreferred experience for the role: • Overall ~3 years of authoring/editing experience in medical writing domain across different therapeutic areas in clinical documents including clinical study protocol, pediatric investigation 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 • Good 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.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. o Provide required source documents incl. information pertaining to study documentation, relevant project contacts (authors, reviewers), developmental strategy o Actively participate in Regulatory Affairs Functional or other cross functional team meetings o Review content of document prior to finalization to ensure high quality prior to initiation of author review or Expert Team Review.Interested candidates may apply for this position.Best Regards, Megha Dixit - TCS HR