Synergen hiring!
Position: Sr.Research Associate
Department: PB (Project Management and Bio-Pharmaceutics)
Qualification: MSC, B. Pharm, M. Pharm
Experience: 02 to 04+ year’s
No Vacancy: 02
Note: Immediate joiner preferred
Job Location: Shivajinagar, Wakadewadi Pune.
Tasks Responsibilities:
- Preparation of Clinical Study Reports (CSR) for EMEA, WHO, SAHPRA, IGA, US-FDA, Costa Rica, others regulatory and Appendices and formats as per projects
- Proficient in e-CTD (both new and paper to e-CTD) Scan, bookmark, hyperlink, optimization, fast-web view apply inherit zoom, and create Table of Contents (TOC) for PDFs
- Preparation of regulatory summary reports for different regulatory BTIF (for WHO), SAHPRA (for South Africa), BSIF (for TGA), DBE (for US-FDA), FOREBI (for Costa Rica) and m 2.7.1 Presentation of Biopharmaceutical and Bioanalytical data (for MHRA, EMEA, NPRA- Malaysia and ROW)
- Knowledge of SDTM, particularly related to BABE studies.
- Resolving queries from regulatory.
- Interested Candidate Share CV on [email protected]
