Assistant Manager – Medical Affairs – COD Research

Job Description :

Key Responsibilities:

Literature search to prepare, review, and finalization of any clinical/non-clinical document.
Preparation or review in support of feasibility and related proposal & synopsis.
Preparation or review of Investigator Brochure, Investigational Medicinal Product/ Investigational Medical Device Dossier etc.
Preparation and review of various clinical trial documents like clinical study protocol / clinical investigation plan, informed consent documents, patient diary cards, clinical study report/clinical investigational report and similar other documents etc.
Preparation and review of common technical documents • Preparation and review of briefing documents for various regulatory bodies.
Preparation and review of Standard Operating Procedures (SOPs)
To assist medical monitor in preparation and review of medical monitoring plan and safety management plan.
To assist medical monitor in review of medical data
To assist the medical monitor or compliance manager in handling of data safety monitoring board-related activities.
To manage medical writing-related activities within the organization
Authorized and responsible to monitor the quality objectives that have been established for the medical writing-related functions and reporting its compliance to the top management.
Authorized and responsible to release relevant services to clients as per requirement.
To address regulatory queries.
To perform any other activities assigned by Head- MA or the management.