Medical Writing Associate II

Job description: Preparation of Clinical Study Report, Appendices, Bio-summary Tables, Module 2.7 and CS-BE Tables. eCTD processing of final clinical study reports and regulatory upload on designated site. System improvements as required on day-to-day basis. Communication with Stakeholders for Clinical Study Report and addressing the comments. Internal and external stakeholder management. Review and update Project contract, follow up until fully executed. Track Project timelines. Carry out e-archival of documents. System improvements as required on day-to-day basis as per business requirements. Maintenance of electronic Trial Master File (eTMF). Mentor team and as assigned, act as subject matter expert (SME). Project lead when assigned.