Indegene is hiring a skilled Regulatory Writer to join a dynamic clinical research team. If you have hands-on experience authoring Clinical Study Reports (CSRs), Investigator Brochures (IBs), Clinical Protocols, Informed Consent Forms (ICFs), and Clinical Narratives, this opportunity could be your next career move. This role offers hybrid work arrangements across major Indian cities and a path to leadership as a Lead or Associate Manager in regulatory writing.
Key keywords: regulatory writer, CSR authoring, clinical study reports, IBs, clinical protocols, ICFs, clinical narratives, regulatory writing careers, hybrid work India.
Responsibilities
- Lead the preparation and production of regulatory documents, including CSRs, IBs, Clinical Protocols, ICFs, and Clinical Narratives.
- Ensure documents meet global regulatory standards, sponsor expectations, and timelines.
- Collaborate with cross-functional teams (clinical operations, medical writing, safety, and QA) to gather inputs and ensure accuracy.
- Maintain document quality, consistency, and tracability through regulatory life cycle.
- Mentor and guide junior writers, provide editorial oversight, and contribute to process improvements.
Qualifications
- Experience: 5–8 years in regulatory writing within clinical research.
- Proficiency in authoring CSRs, IBs, Clinical Protocols, ICFs, and Clinical Narratives.
- Strong knowledge of ICH-GCP guidelines, regulatory submission standards, and industry best practices.
- Excellent writing, attention to detail, and ability to manage multiple documents and timelines.
- Preferred: experience in a lead or associate manager role; strong collaboration and project management skills.
- Location flexibility: Bangalore, Hyderabad, Mumbai, Pune, Delhi with a hybrid work model.
Benefits
- Hybrid work arrangement with location flexibility.
- Opportunity to lead regulatory writing projects and mentor others.
- Exposure to global regulatory standards and diverse therapeutic areas.
- Competitive compensation and career growth in a fast-growing clinical research organization.
- Professional development and continuous learning resources.
Note: Specific salary details are not provided in the job description; typical INR ranges for this level in India can vary by city and company, but a realistic indicative salary range should be verified with HR.
Location
- Hybrid roles in:
- Bangalore
- Hyderabad
- Mumbai
- Pune
- Delhi
How to Apply
- Send your resume and a brief cover letter to Shloka at Shloka@indegene.com.
