Bio Synergen Hiring Protocol Writers Clinical Research
Bio Synergen, a reputed name in the clinical research and pharmaceutical industry, is inviting applications for the position of Protocol Writer at its Pune office. This is an excellent opportunity for pharmacy graduates with 1 to 2.5+ years of experience in clinical research, regulatory documentation, or protocol writing. Bio Synergen Hiring Protocol Writers Clinical Research
Job Overview
- Company: Bio Synergen
- Location: Shivajinagar, Wakadewadi, Pune
- Job Title: Protocol Writer
- Type: Full-time
- Open Positions: 02
- Experience Required: 1 to 2.5+ years
- Educational Qualification: B.Pharm / M.Pharm
- Preference: Immediate joiners preferred
About the Role
As a Protocol Writer, you will be a part of the Project Management and Biopharmaceutics team, responsible for preparing essential clinical research documents in compliance with regulatory and sponsor requirements. The role demands high attention to detail, technical writing expertise, and the ability to coordinate with cross-functional teams. Bio Synergen Hiring Protocol Writers Clinical Research
Key Responsibilities
- Develop Study Synopses, Feasibility Reports, and Clinical Study Protocols in accordance with ICH-GCP and sponsor guidelines
- Draft and review Informed Consent Documents (ICD) in both English and regional languages
- Compile Clinical Study Reports (CSR) and ensure consistency with raw data and timelines
- Collaborate with clinical, bioanalytical, and investigator teams for data collection and interpretation
- Submit and coordinate documents with Ethics Committees (EC) for approvals
- Prepare Standard Operating Procedures (SOPs) and CTD modules including Module 5 and Module 2.7
- Write confinement reports, annual summaries, and periodic sponsor updates
Desired Candidate Profile
- Education: B.Pharm or M.Pharm
- Experience: 1 to 2.5+ years in protocol writing or clinical documentation
- Skills Required:
- Strong knowledge of ICH-GCP and regulatory frameworks
- Proficiency in technical and scientific writing
- Familiarity with clinical trials, SOPs, and ethical submission processes
- Good communication and coordination skills
About Bio Synergen
Bio Synergen is a well-established organization in the pharmaceutical and clinical research domain. The company is known for its expertise in biopharmaceutics, regulatory compliance, and project management. Located in Pune, Bio Synergen offers a collaborative work environment that supports innovation, learning, and career advancement. Bio Synergen Hiring Protocol Writers Clinical Research
How to Apply
Interested and eligible candidates should send their updated resume to:
Email: careers@synergenbio.com
Subject Line: Application for Protocol Writer – Pune
Why Join Bio Synergen?
- Work with an experienced and dedicated team in clinical research
- Exposure to international regulatory standards
- Growth opportunities within the pharmaceutical and biotech sector
- Supportive and compliance-driven work culture
Conclusion
If you’re a pharmacy graduate with relevant experience in clinical research documentation, don’t miss this opportunity with Bio Synergen in Pune. This role provides a solid foundation for advancing in the clinical research field, especially in protocol and regulatory writing. Bio Synergen Hiring Protocol Writers Clinical Research
Apply today and take the next step in your pharmaceutical career.
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