Synergen Bio Seeking Immediate Joiners for Project Management and Bio-Pharmaceutics Roles
Synergen Bio, a leading name in the biopharmaceutical industry, is currently seeking immediate joiners for the position of Senior Research Associate in the Project Management and Bio-Pharmaceutics department. This role is based in Pune, Maharashtra, and offers an exciting opportunity for qualified professionals to contribute to cutting-edge pharmaceutical projects.
Qualifications and Experience
- Required Qualifications: MSc in Life Sciences, B Pharmacy, M Pharmacy
- Experience: 2 to 4+ years of relevant experience in project management and bio-pharmaceutics
- Preferred: Candidates who can join immediately
This role is ideal for individuals with a strong background in pharmaceutical sciences and project management, looking to advance their career in a dynamic and fast-paced environment.
Job Responsibilities
As a Senior Research Associate in Project Management and Bio-Pharmaceutics, you will be responsible for:
- Clinical Study Reports (CSR): Preparing CSRs for various regulatory bodies, including EMEA, WHO, SAHPRA, TGA, US-FDA, and Costa Rica, among others.
- e-CTD Proficiency: Managing electronic Common Technical Documents (e-CTD), including scanning, bookmarking, hyperlinking, optimization, and applying fast-web view. Creating and managing Tables of Contents (TOC) for PDFs.
- Regulatory Summary Reports: Compiling regulatory summary reports for different international bodies such as WHO, SAHPRA, TGA, US-FDA, and others.
- Biopharmaceutical Data Presentation: Preparing and presenting biopharmaceutical and bioanalytical data for regulatory submissions, including those for MHRA, EMEA, NPRA-Malaysia, and other regions.
- SDTM Knowledge: Applying knowledge of Study Data Tabulation Model (SDTM), particularly in relation to Bioavailability and Bioequivalence (BABE) studies.
- Regulatory Queries: Resolving queries from regulatory authorities, ensuring all submissions meet the required standards and timelines.
Location:
Shivajinagar, Wakadewadi, Pune, Maharashtra
Application Process
Please share your updated CV with the relevant details at careers@synergenbio.com.
