Medical Writing

TCS is hiring for Medical Writing Role!!!

Job Description: 

• 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