Synergen Bio Private Limited is a DCGI(CDSCO) approved new age CRO with all necessary infrastructure to cater to the Pharmaceutical and Biotech industry, established by a group of enthusiastic professionalswith a vision to set-up a premium Clinical Research Organization known for its Quality, Knowledge and Expertise. Synergen Bio understands the importance of quality clinical research services and our significantly experienced team strives to provide the same to our sponsors at significant cost advantages. Representing a vertically integrated CRO, we offer customised solutions to suit sponsor requirements for the full spectrum of clinical research.
Post : Medical Writer
Qualification : B.Pharm / M.Pharm
Experience : 0 to 2+ year's
Note : Immediate joiner preferred.
Job Location : Shivajinagar, Wakadewadi Pune.
Responsibilities :
• 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 rules 2019, FDA, EMA, TGA, DCGI and other regulatory guidance's for BABE 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
Last Date : 10th August, 2023
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