Senior Business Analyst - Medical Writing

Position : Medical writer

Reporting to : Team Lead

Work Location : Mumbai - Mahape

Night Shift/ Rotational Shifts : NA

Educational Qualifications : Medico/ M Pharm Life science Graduate

Desired Experience Level in Years : minimum 3 to 5 years Medical Writing experience

Major Deliverables :

- Prepare high quality Clinical documents like Clinical Study Report(CSR), Protocols, Narratives, ICFs, Investigators Brochure, Clinical Trial Registry Summaries, eCTD modules and Post Approval Documents across the Therapeutic Areas.

- Perform Quality check and review of the clinical documents

- Prepare and Quality Check clinical disclosure documents (FDAAA) in compliance with Standard Operating Procedures, Document Standards and Guidance document. Ensure uniformity and consistency in the FDAAA and revise the document as per the comments from the study team members