Synergen Bio Pvt. Ltd. is a leading name in the pharmaceutical and clinical research industry, specializing in biopharmaceutical research, clinical trials, and regulatory compliance. With a strong commitment to innovation and quality, Synergen Bio provides end-to-end solutions for clinical research organizations (CROs) and pharmaceutical companies.
Job Description: Protocol Writer
Key Responsibilities:
- Preparation of Study Synopsis and Study Feasibility Reports for clinical studies.
- Drafting, reviewing, and finalizing study protocols as per sponsor and regulatory guidelines.
- Preparing and reviewing Informed Consent Documents (ICD) in English and vernacular languages.
- Compiling Clinical Study Reports (CSR) within timelines, ensuring regulatory compliance.
- Coordinating with clinical teams, bioanalytical departments, and investigators for data compilation.
- Interpreting study outcomes in collaboration with the Principal Investigator (PI).
- Submitting study documents to Ethics Committees (EC) and obtaining approvals.
- Developing and reviewing Standard Operating Procedures (SOPs).
- Preparing Module 5 (Clinical Study Reports), Module 2.7, and Bio-Summary Tables.
- Drafting Confinement Reports and Annual Summary Reports.
Desired Skills & Qualifications:
- Strong understanding of clinical research protocols, ICH-GCP, and regulatory guidelines.
- Excellent scientific writing, documentation, and communication skills.
- Ability to work in a fast-paced, deadline-driven environment.
- Proficiency in Microsoft Office & clinical trial software.
How to Apply?
Interested candidates can share their updated CV/Resume to:
📧 Email: careers@synergenbio.com