Location: Shivajinagar, Wakadewadi, Pune
Positions: 02
Experience: 1 to 2.5+ years
Qualification: B.Pharm / M.Pharm
Job Type: Full-time (Immediate joiners preferred)
Job Description
Bio Synergen is seeking a skilled Protocol Writer to join its Project Management and Biopharmaceutics team in Pune. The role involves critical responsibilities in clinical research documentation, regulatory compliance, and cross-functional collaboration.
Key Responsibilities:
- Prepare Study Synopses, Feasibility Reports, and Clinical Study Protocols per sponsor/regulatory guidelines.
- Draft and review Informed Consent Documents (ICD) in English and vernacular languages.
- Compile Clinical Study Reports (CSR) within timelines, ensuring alignment with raw data and regulations.
- Coordinate with clinical teams, bioanalytical departments, and investigators for data compilation and interpretation.
- Liaise with Ethics Committees (EC) for document submissions and approvals.
- Develop Standard Operating Procedures (SOPs) and regulatory modules (Module 5, Module 2.7).
- Prepare confinement reports, annual summaries, and sponsor updates.
About Bio Synergen
Bio Synergen is a reputed player in the pharmaceutical and clinical research domain, specializing in biopharmaceutics and project management. With a commitment to innovation and compliance, the company fosters a collaborative work environment for professionals to grow in the healthcare and pharma industry.
Eligibility Criteria
- Education: B.Pharm / M.Pharm (Pharmacy graduates preferred).
- Experience: 1–2.5+ years in clinical research, protocol writing, or regulatory documentation.
- Skills:
- Proficiency in clinical study reports, ICH-GCP, and regulatory guidelines.
- Strong technical writing and attention to detail.
- Ability to work with cross-functional teams.
How to Apply
Eligible candidates can share their updated CV to careers@synergenbio.com with the subject line “Application for Protocol Writer – Pune”.
