Synergen Bio Hiring for Project Management and Biopharmaceutics Role

Synergen Bio is hiring for its Project Management and Biopharmaceutics division, offering a great career opportunity for skilled Protocol Writers in Pune, Maharashtra. This role is perfect for candidates with qualifications in B Pharm or M.Pharm and 1 to 2.5+ years of relevant industry experience. There are currently two vacancies available at their Shivajinagar, Wakadewadi facility. Interested and qualified candidates are encouraged to apply immediately.

Job Overview: Protocol Writer – Project Management and Biopharmaceutics

Company: Synergen Bio

Position: Protocol Writer

Department: Project Management and Biopharmaceutics

Qualification Required: B Pharm / M.Pharm

Experience: 1 to 2.5+ years

No. of Vacancies: 02

Location: Shivajinagar, Wakadewadi, Pune, Maharashtra

Preference: Immediate Joiners

Key Responsibilities:

• As a Protocol Writer at Synergen Bio, the selected candidate will be responsible for handling critical documentation and coordination tasks essential for the successful execution of clinical studies:
• Preparing study synopses and performing feasibility assessments for upcoming clinical trials.
• Drafting and reviewing clinical trial Protocols in accordance with sponsor requirements and global regulatory guidelines.
• Designing and verifying Informed Consent Documents (ICDs) in both English and regional languages to ensure clarity and compliance.
• Compiling and delivering Clinical Study Reports (CSR) within specified timelines, based on trial data and adhering to regulatory frameworks.
• Facilitating close coordination with cross-functional teams including Clinical, Bioanalytical, Principal Investigators, and Co-Investigators during data compilation and report preparation.
• Assisting in the interpretation of study outcomes under the guidance of the Principal Investigator.
• Preparing timely Clinical Study Updates and communicating these to sponsors and Ethics Committees (EC).
• Handling Ethics Committee submissions, ensuring accurate documentation and obtaining necessary study approvals.
• Reviewing and drafting internal Standard Operating Procedures (SOPs) for compliance and process optimization.
• Compiling Module 5 Clinical Study Reports and Module 2.7 Bio-summary Tables as part of the dossier.
• Preparing detailed Confinement Reports and
• Annual Summary Reports for regulatory submissions.

Qualification & Experience:

• Educational Requirement: B Pharm or M.Pharm degree from a recognized university.
• Work Experience: Minimum 1 year to 2.5+ years in Clinical Research or related field.
• Key Skills: Protocol Writing, CSR Preparation, Regulatory Compliance, SOP Development, Ethical Committee Communication.
• Vacancy Information:
• Total Open Positions: 02
• Employment Type: Full-time
• Preferred Joining: Immediate joiners will be given priority.

Job Location:

📍 Synergen Bio Pvt. Ltd.

Shivajinagar, Wakadewadi, Pune, Maharashtra, India.

How to Apply?

If you meet the qualification and experience criteria and are looking to grow your career with a reputed clinical research organization, please send your updated CV to:

📧 Email: careers@synergenbio.com