Scientific Writing Job at Indegene | MBBS Graduates Apply Online
Indegene is hiring a Senior Associate – Scientific Writing with 4–6 years of experience in authoring clinical and regulatory documents supporting global filings. The Scientific Writing Job involves leading medical writing deliverables, mentoring junior writers, coordinating cross-functional teams, and ensuring compliance with regulatory guidelines. Ideal candidates hold MBBS, PhD, MDS, BDS, MPharm, or PharmD degrees and have expertise in CTD Modules 2 and 5, clinical study reports, protocols, and investigator brochures.
- Job Post: NT -Senior Associate – Scientific Writing
- Location: Karnataka, India
Introduction
We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy.
Scientific Writing Job Description
They are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force.
Must Have:
- Education: MBBS/PhD/MDS/BDS/MPharm/PharmD
- Experience: 4 to 6 years’ experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5)
- Role Purpose: Lead Medical Writer is responsible for the development and review of medical writing deliverables that support the clinical regulatory writing portfolio and train the junior writers.
Skills
- Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs,) protocols, amendments, and Investigator Brochures (IBs)
- Demonstrated excellence in focused/lean writing and editing following defined processes and templates
Knowledge Requirement
Scientific Knowledge:
- Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States
- Ability to interpret data and apply scientific knowledge to support regulatory document writing (i.e., IB, protocols, amendments, CSR, Clinical summaries)
- Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science
Responsibilities of the Scientific Writing Job
Without guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development
Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of the authoring process
