Job Title: Protocol Writer
Experience Required: 3–4 Years
Educational Qualification: B.Pharm / M.Pharm / Pharm D
Location: Ahmedabad
Job Description
We are looking for a Protocol Writer to join our dynamic team in Ahmedabad. The ideal candidate will have experience in writing and developing protocols for clinical research. As a Protocol Writer, you will be responsible for drafting, reviewing, and finalizing clinical trial protocols, ensuring adherence to regulatory standards and providing high-quality documents that align with the clinical development strategy.
Key Responsibilities
Protocol Development:
Write and edit clinical trial protocols, informed consent forms (ICFs), and other regulatory documents.
Ensure protocols are aligned with study objectives, regulatory requirements, and ethical guidelines.
Work closely with clinical research teams, project managers, and subject matter experts to gather and incorporate relevant information into protocols.
Regulatory Compliance:
Ensure that protocols are in compliance with applicable regulatory guidelines (e.g., ICH-GCP, FDA, EMA).
Provide guidance on regulatory requirements and assist in the submission process for ethics committee and regulatory authority approvals.
Collaboration:
Coordinate with cross-functional teams, including clinical operations, biostatistics, regulatory affairs, and medical writing, to ensure the protocol reflects the study design and objectives accurately.
Assist in the preparation of other study-related documents, such as investigator brochures, clinical study reports (CSRs), and study manuals.
Review and Revisions:
Review and revise protocols as needed, based on feedback from stakeholders.
Incorporate necessary updates to protocols based on evolving study requirements, regulatory changes, and feedback from clinical teams.
Document Management:
Maintain an organized system of protocol documents, ensuring proper version control and documentation of changes.
Ensure that all protocols are accurately filed and accessible for future reference.
Candidate Requirements
Educational Background:
B.Pharm, M.Pharm, or Pharm D with a strong understanding of clinical research and protocol writing.
Experience:
3–4 years of experience in clinical research or protocol writing, with hands-on experience drafting protocols for clinical trials.
Skills and Knowledge:
Strong knowledge of clinical research processes, ICH-GCP guidelines, and regulatory requirements.
Ability to write clear, concise, and accurate clinical trial protocols.
Familiarity with clinical trial design, statistical analysis plans, and study logistics.
Strong attention to detail and the ability to ensure compliance with regulatory standards.
Communication Skills:
Excellent written and verbal communication skills, with the ability to present complex information in a clear and concise manner.
Analytical and Organizational Skills:
Strong analytical skills to understand clinical trial designs and protocols.
Ability to manage multiple projects and meet deadlines in a fast-paced environment.
Detail-oriented with excellent organizational skills.
Why Join Us?
Competitive salary and benefits.
Opportunities for professional growth and career advancement.
Work in a collaborative, innovative environment focused on excellence in clinical research.
Be part of an industry leader in the field of pharmaceutical and clinical development.
Make a direct impact on the success of clinical trials and patient outcomes.
If you have the experience and qualifications for the Protocol Writer position and are passionate about clinical research, apply today to join our team in Ahmedabad!
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