Manager - Medical Writer

Position - Manager -Medical Writer
Department - Medical Affairs 

Job Responsibilities:

• Designing of preclinical studies as per the regulatory requirements to support the clinical bridging.
• Preparation and review of preclinical study synopsis, study protocol and reports.
• Preparation and Review of clinical development strategies.
• Preparation and Review of clinical study synopsis.
• Preparation and review of regulatory submission documents like Scientific advice, Pre­ IND package, controlled correspondence.
• Preparation and review of Initial pediatric study plans (iPSP).
• Identification of unmet needs through active stakeholder interactions and actively contributes in the new product ideation and development of differentiated products.
• Preparation of slides on medical rationale for differentiated products.
...