Synergen Bio Hiring B.Pharm, M.Pharm Candidates as Protocol Writer

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 : Protocol Writer

Department : Project Management and Biopliarmaceutics
Qualification : B.Pharm, M.Pharm
Experience : 1 to 2.5+ year's
No Vacancy : 02
Job Location : Shivajinagar, Wakadewadi, Pune.

Tasks Responsibilities
• Preparation of Study synopsis and Study feasibility for the clinical study
• Preparation and review of Protocol as per sponsor and various regulatory requirements.
• Preparation and review of Informed Consent Document (IC’D) in English and vernacular language according to protocol.
• Preparation of Clinical Study Repoxt (CSR) within proposed time line according to raw data and as per the regulatory requirements.
• Coordination with clinical. Bioanalytical Department and Principal and co-investigators while preparation of Clinical Study Reports and compilation of data.
• Interpretation of study outcome in coordination with Principal Investigator.
• Preparation of Clinical Study Updates and inform to the sponsor and Ethics Committee.
• Coordination with Ethics Committee (EC) in submission of study related document and obtain approval.
• Preparation and review of in-house Standard Operating Procedure (SOP).
• Module 5 clinical study report compilation & module 2.7 and bio-summary table preparation.
• Confinement report preparation and Annual summary report preparation.

Note : Immediate joiner preferred