Navitas Life Sciences has openings for Medical Writing Services Department

Roles: Medical Writer, Lead Medical Writer   

Locations: Bangalore, WFH (Home Based)

Job related experience: The ideal candidate must possess a good understanding of clinical trials and drug development, have a sound knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research. Preferred experience in eCTD authoring, protocol, IB, CSR reports, Clinical trials (phase I, II, III, IV). Must demonstrate a robust understanding of how to interpret, describe and document clinical data and must have excellent English language skills (verbal and written).
Responsibilities*:
Ø  Developing Clinical Study Outlines
Ø  Designing protocols for clinical trials Phase I to IV
Ø Preparation of Clinical Study Reports for Phase I to IV clinical trials studies for submission to regulatory authorities
Ø  Preparation of Common Technical documents (CTD) for Regulatory Authority submission
Ø Preparation of Manuscript ICF, PIS, IB’s and PSUR
Ø Protocol briefing sessions of clinical operations, statisticians & data management team
Ø  SAE Narrative preparation
Ø  Departmental SOP preparation and revision
Ø Support to Business Development in preparation of clinical trial proposals
Ø Feasibility analysis for the clinical trials by discussing with specialists in various therapeutic areas
Ø  Preparing Feasibility questionnaires to support Clinical Operations.

Interested candidates, kindly connect with Nancy Daniel (HR Associate) on LinkedIn and share your CV