Assistant Manager - Medical Affairs

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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