Medical Writing - Scientific Support- Clinical Job @ PIRAMAL, MUMBAI "D4"

Job Description:

Excellent interpersonal, verbal and written communication skills 
Demonstrated understanding of the drug development process and a broad knowledge of FDA and DCGI guidelines. 
Extensive clinical/scientific writing skills. 

Experience:

2-3 years

Job Responsibilities: 

·         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 Investigator’s 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 support for 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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