pharmaceuticalcarrier.com Pharma Career Pharmaceutical Career Guidance and Jobs

Opportunity to work as Protocol Writer at Synergen- Apply before 15th April 2024

Synergen Bio Pharma Ltd
Pharmacareer

Website Synergen

About Synergen

Synergen Bio Private Limited is a DCGI (CDSCO) approved Contract Research Organization (CRO) equipped with the essential infrastructure to serve the Pharmaceutical and Biotech industry. The organization was established by a group of enthusiastic professionals who share a vision of creating a top-tier Clinical Research Organization known for its commitment to Quality, Knowledge, and Expertise.

Synergen Bio recognizes the critical role that quality clinical research services play in the pharmaceutical and biotech sectors. The team, which boasts significant experience, is dedicated to delivering high-quality services to sponsors, while also providing them with cost advantages.

Job Post: Protocol Writer

Department: Project Management and Biopharmaceutics

Qualification: B.Pharm, M.Pharm

Experience: 1 to 2.5+ years

No Vacancy: 02

Job Description:

  • Prepare Study Synopsis and Study Feasibility for clinical studies.
  • Draft and review Protocols in accordance with sponsor and regulatory requirements.
  • Create and review Informed Consent Documents (ICD) in English and vernacular languages as per protocol.
  • Generate Clinical Study Reports (CSR) within proposed timelines and regulatory guidelines.
  • Coordinate with clinical and Bioanalytical Departments, Principal Investigators, and co-investigators during CSR preparation and data compilation.
  • Interpret study outcomes in collaboration with Principal Investigator.
  • Prepare Clinical Study Updates and provide periodic updates to sponsors and Ethics Committee (EC).
  • Coordinate with EC for submission of study-related documents and obtain approvals.
  • Draft and review in-house Standard Operating Procedures (SOPs).
  • Compile Module 5 clinical study reports and prepare Module 2.7 and bio-summary tables.
  • Prepare Confinement reports and Annual summary reports.

Note:

Immediate joiner preferred.

Job Location:

Shivajinagar, Wakadewadi, Pune.

Interested candidates, please share your CV at careers@synergenbio.com

Last Date: 15th April 2024

To apply for this job email your details to careers@synergenbio.com