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 ide...