Bio Synergen is a leading name in the biopharmaceutical and clinical research industry, dedicated to delivering high-quality research and regulatory-compliant solutions. With a strong focus on innovation and precision, Bio Synergen provides a dynamic work environment for professionals looking to grow in the field of clinical research and regulatory submissions.
Job Description (Key Responsibilities)
As a Research Associate (Report Writer), you will be responsible for:
✔ Preparing Clinical Study Reports (CSR) within the proposed timeline, ensuring compliance with regulatory requirements.
✔ Creating electronic copies of final study reports (scanning, bookmarking, hyperlinking, inheriting zoom, and generating TOC for PDFs).
✔ Ensuring adherence to eCTD specifications for regulatory submissions.
✔ Coordinating with clinical & bioanalytical departments, principal investigators, and co-investigators for CSR preparation and data compilation.
✔ Uploading clinical data (demographics, lab values, vital signs, meal distribution, and sample time deviations).
✔ Preparing regulatory summary reports (Module-02) and clinical study reports (Module-05) in eCTD format.
✔ Assisting in project-related coordination across different departments.
Desired Skills & Qualifications
- MSc, B.Pharm, or M.Pharm degree.
- 1.5+ years of experience in clinical research, regulatory writing, or report preparation.
- Strong knowledge of eCTD guidelines and regulatory submissions.
- Proficiency in PDF editing tools (bookmarking, hyperlinking, TOC creation).
- Excellent communication & coordination skills.
How to Apply?
Interested candidates can share their updated CV at careers@synergenbio.com with the subject line “Application for Research Associate (Report Writer) – Pune”.
📍 Job Location: Shivajinagar, Wakadewadi, Pune
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No. of Vacancies: 02
Job Location: Shivajinagar, Wakadewadi, Pune
