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Position: Sr. Manager
Department: Project Management and Biopharmaceutics
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Qualifications:
- B. Pharm, M.Pharm, MSc
Experience:
- 10+ years
Vacancies: 01
Preferred: Immediate joiner
Location: Shivajinagar, Wakadewadi, Pune
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Tasks and Responsibilities:
- Team Leadership: Lead the Bio-PK team to plan and execute BA/BE studies for various regulatory markets.
- PK Study Design: Manage the design of PK studies for demonstrating bioequivalence (BE) for solid, liquid, topical, and specialized dosage forms, including parental.
- Research and Writing: Conduct extensive literature searches, medical narrative writing, and summary report writing.
- Cross-functional Coordination: Coordinate with all cross-functional teams to support and develop clinical research projects.
- Pilot Study Review: Review and evaluate pilot bio-study clearance reports and results before initiating pivotal bio studies to ensure success.
- Protocol Development: Develop, review, and recommend scientifically supported PK study BE protocols for ANDAs.
- Study Report Review: Review draft and final BE study reports to ensure compliance with scientific and regulatory requirements.
- Medical Writing Management: Oversee and manage all medical writing activities.
- Client Support: Provide support to clients regarding CRO services.
- Risk Management: Proactively identify risks in ongoing studies and resolve issues in consultation with respective departments and sponsors.
- Document Preparation: Prepare service agreements and other confidential documents.
- Logistic Support: Ensure logistical support from sponsors.
- Regulatory Submission: Submit DCGI NOC documents to the office of DCGI for BA/BE study approval on time.
- Project Slotting: Coordinate with clinical operations and screening teams for project slotting.
Interested candidates can share their CVs at: careers@synergenbio.com
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