Highlights of Job
• Job Title :- Medical Writer
• Location :- Pune
• Qualification :- B Pharm / M Pharm
• Experience :- 0 - 2 Year's
• Salary :- Not Mentioned.
Job Details
• Preparation and review of protocol as per sponsor and regulatory requirements.
• Preparation and review of feasibilities and submission in co-ordination with Clinical,
Bioanalytical and statistical departments.
• Preparation and review of Informed Consent Document (ICD) in English and vernacular
language according to protocol.
• Preparation of Clinical Study Report (CSR) within proposed time line according to raw
data and as per the regulatory requirements.
• Knowledge of ICH-E6 GCP, E3 guidance, NDCT 2019, FDA, EMA TGA, DCGI and other regulatory guidance's for BA/BE studies.
• Coordination with Clinical, Bioanalytical, Principal and co-investigators while preparation
of Clinical Study Protocol, Reports and compilation of data.
• Preparation of Clinical Study Updates and inform to the sponsor and Ethics Committee
(EC) periodically.
• Preparation and review of in-house Standard Operating Procedure (SOP).
• Module 5 clinical study report compilation & module 2.7 and bio-summary table
preparation.
Interested Candidate Share CV on careers@synergenbio.com
How to Apply
1) Click Above E Mail link/ Copy
2) Send your updated CV/ Resume
3) Wait for reply.
Recruitments Starting
26th July 2023
