Medical Writer

Medical Writer, Mumbai, Maharashtra

Piramal Glass Ltd. (PGL)

Job Description:

Perform Medical Writing activities on the assigned project in a timely and efficient manner
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
To develop Clinical Trial protocols
To author Clinical Study Reports for Phase 1-4 trials, including full study reports and abbreviated reports
Ensure high quality, timely communication and project information flow to the Head, Scientific support clinical
To help in drafting Investigators Brochure and IB updates once clinical strategy is finalized. To assist in template development and management of company specific templates
To assist in maintaining a standard format for various types of documents that are needed for regulatory submission
To review SAP and provide inputs
To review SAR and provide inputs
To provide research information required for a particular therapeutic area available to all team members as required
Write various regulatory reports for Indian as well as global regulatory submissions To edit pre-clinical reports required for IND submissions
To author summaries of pre-clinical reports for inclusion into the Investigators Brochure
To liaise with pre-clinical development and discovery departments to provide medical writing supportfor key reports
Perform Quality control of written documents and ensure they meet the required standards
Development of SOPs and processes for Medical Writing in compliance to regulatory requirements
To keep up-to-date with new development and research in medical arena of drug development as appropriate
Ensure compliance of operations with governing regulatory requirements
Create, maintain and assume accountability for a culture of high customer service.

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