Intas Pharmaceuticals General Manager Clinical Development (8 16 Yrs)
Job Description
Summary:
Handle clinical development and medical affairs efficiently with following responsibilities
- Clinical and Non-Clinical development for different markets
- Support Device development
- Medical writing
- Regulatory support
- Support PVG activity
- Work in collaboration with stake holders and implement assigned activity
Responsibilities
- Responsible for the following activities Clinical and non-clinical development for Global, RoW and National market
- Clinical development plan, Scientific advices
- Preparation of synopsis for expansion to protocol by CRO
- Conduct of the trial
- Medical writing
- Support product evaluation
- Regulatory support activities
- Regulatory query handling for clinical and PVG
- Prepare or review PI
- Prepare regulatory submission dossier for clinical and animal studies Device development support
- Support HF study conduct Support PVG activity
- Identifying ADR from complaints
- Preparation or review of individual cases, PSUR, RMP
- Support Biotech and Plasma fraction related PVG work
Additional Responsibilities
- Work in collaboration with Intas Pharma, Accord and CRO to implement activities
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Job Detail
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Job IdJD2970345
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationAhmedabad, Gujarat, India
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EducationNot mentioned
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ExperienceYear