Synergen Bio Private Limited is a DCGI (CDSCO)-approved Clinical Research Organization (CRO) offering end-to-end clinical research solutions for pharmaceutical and biotech industries. Established by a team of passionate professionals, Synergen Bio is committed to delivering high-quality, cost-effective clinical research services with expertise in regulatory compliance and project management.
With a focus on innovation, quality, and efficiency, Synergen Bio provides customized clinical trial solutions, including protocol development, clinical study reports, bioanalytical services, and regulatory submissions.
Job Opening: Protocol Writer
Department: Project Management & Biopharmaceutics
Qualification: B.Pharm / M.Pharm
Experience: 1 to 2.5+ years
Vacancies: 02
Job Location: Shivajinagar, Wakadewadi, Pune
Key Responsibilities:
- Preparation of study synopsis and feasibility reports for clinical trials.
- Drafting and reviewing clinical trial protocols as per sponsor and regulatory (DCGI, ICH-GCP) guidelines.
- Developing Informed Consent Documents (ICD) in English and regional languages.
- Compiling Clinical Study Reports (CSR) within timelines, ensuring regulatory compliance.
- Coordinating with clinical, bioanalytical teams, and investigators for data compilation and interpretation.
- Liaising with Ethics Committees (EC) for approvals and submissions.
- Preparing Module 5 (Clinical Study Reports), Module 2.7, and bio-summary tables for regulatory filings.
- Drafting confinement reports and annual summary reports.
- Reviewing and updating Standard Operating Procedures (SOPs).
Preferred Candidate Profile:
- B.Pharm / M.Pharm graduates with 1-2.5 years of experience in clinical research, protocol writing, or regulatory submissions.
- Strong understanding of ICH-GCP, DCGI, and CDSCO guidelines.
- Excellent scientific writing and documentation skills.
- Ability to work in a fast-paced CRO environment.
- Immediate joiners preferred.
How to Apply?
Interested candidates can share their updated CV at careers@synergenbio.com before June 20, 2025.
Note: Only shortlisted candidates will be contacted for further selection processes.