Synergen Bio Hiring for Protocol Writer Jobs – Your Gateway to a Thriving Career in Clinical Research
In the ever-expanding world of clinical research and biopharmaceuticals, the role of a Protocol Writer has become increasingly essential. If you’re a skilled professional with a background in B. Pharm or M. Pharm and looking for opportunities in Pune, the job opening at Synergen Bio might just be the career breakthrough you’re seeking. With two immediate vacancies available at their Wakadewadi, Shivajinagar office, this could be your chance to join a reputed organization in a highly specialized field.
What Does a Protocol Writer Do?
The position of a Protocol Writer is critical in ensuring that clinical trials are effectively planned, executed, and documented. Professionals in this role bridge the gap between scientific research, regulatory requirements, and clinical execution.
Key Responsibilities of the Protocol Writer Role
At Synergen Bio, the Protocol Writer will undertake a variety of essential tasks that contribute to the success of clinical studies and trials. Here’s a comprehensive look at the responsibilities:
Preparation of Study Synopsis and Feasibility Reports
One of the initial stages of clinical study involves the drafting of a study synopsis and conducting a feasibility assessment. This task ensures that the proposed clinical study is practical and aligns with scientific and logistical standards.
Development and Review of Clinical Protocols
The role requires in-depth knowledge to develop and review protocols that align with the sponsor’s requirements and regulatory standards. This documentation lays out the blueprint for the clinical trial process.
Informed Consent Documentation (ICD)
Ensuring that Informed Consent Documents are accurate and translated into vernacular languages is vital. The Protocol Writer will be responsible for reviewing ICDs to ensure they comply with regulatory standards and are understandable to participants.
Clinical Study Report (CSR) Preparation
Compiling a Clinical Study Report (CSR) within defined timelines and regulatory frameworks is another critical task. This report synthesizes raw data and outcomes into a clear, structured document.
Interdepartmental Coordination
The role involves cross-functional coordination with clinical, bioanalytical departments, and principal investigators. This helps streamline data collection and reporting.
Interpretation of Study Outcomes
You will work closely with the Principal Investigator to analyze and interpret study results, offering scientific input to enhance accuracy and reliability.
Communication with Ethics Committees
The Protocol Writer is also responsible for preparing documentation for submission to Ethics Committees (ECs) and ensuring that all necessary approvals are secured in a timely manner.
Preparation of SOPs and Module 5 Reports
Experience in drafting Standard Operating Procedures (SOPs) and Module 5 clinical study report compilations, including module 2.7 and bio-summary table preparation, is highly valued.
Report Generation
Additional responsibilities include confinement report preparation and the generation of annual summary reports, offering a comprehensive view of the study over time.
Who Should Apply?
This job is ideal for professionals who possess:
A degree in B. Pharm or M. Pharm
1 to 2.5+ years of experience in clinical research documentation
Familiarity with clinical trial protocols, SOPs, and regulatory documentation
Exceptional attention to detail, strong analytical skills, and the ability to manage multiple projects simultaneously
Proficiency in English and at least one vernacular language for ICD preparation
Why Choose Synergen Bio?
Located in the heart of Pune, Synergen Bio stands out as a premier employer in the biopharma and clinical research industry. The company promotes a collaborative work culture, encourages career growth, and prioritizes regulatory compliance and innovation in every project.
Benefits of Joining Synergen Bio:
Work in a scientifically rigorous environment
Collaborate with experienced professionals across multiple departments
Opportunity to be involved in cutting-edge research and global studies
Structured career development programs
Competitive compensation and immediate joining opportunities
Location Advantage – Shivajinagar, Wakadewadi, Pune
The job location in Shivajinagar, Wakadewadi places you in one of Pune’s most accessible and vibrant neighborhoods. With convenient public transport, quality infrastructure, and a professional ecosystem, you’ll thrive both professionally and personally.
How to Apply
Interested candidates are encouraged to share their CV at [email protected]. Given that the organization is seeking immediate joiners, early applicants are likely to be prioritized.
Conclusion: Your Career as a Protocol Writer Starts Here
A Protocol Writer role at Synergen Bio offers more than just a job — it’s a chance to be part of a transformational industry that is redefining global healthcare. With a focus on precision, compliance, and innovation, this opportunity is tailor-made for driven individuals looking to make an impact.
If you are passionate about clinical research, have the right educational background and experience, and are eager to contribute meaningfully to drug development and public health, this role is your gateway to a fulfilling career.
Don’t miss your chance to apply. Stand out in the clinical research field. Become a Protocol Writer at Synergen Bio.
