Assistant Manager Medical Affairs COD Research Designing Therapies For Future Assistant Manager Medical Affairs Assistant Manager Medical Affairs No. of direct/Indirect reportee : Position report to :

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.

Qualifications :
- Life Science Graduate/Post-Graduate.
- Minimum of 5 Years of CT experience.

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📌 Assistant Manager (Ahmedabad)
🏢 COD Research
📍 Ahmedabad