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Senior Associate - Scientific Writing

4-6 years
Not Disclosed
10 July 31, 2025
Job Description
Job Type: Full Time Education: MBBS, PhD, MDS, BDS, MPharm, PharmD, BPharm, or MSc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Senior Associate – Scientific Writing (Bangalore, India)

Join Indegene's healthcare-tech powerhouse and contribute to impactful regulatory content.

Job Summary:

Indegene is hiring a skilled Senior Scientific Writer with 4–6 years of experience in regulatory writing and reviewing. This hybrid role based in Bangalore is ideal for professionals with clinical and non-clinical content development experience (e.g., CTD Modules 2, 4, and 5). If you're looking to grow your career in a global, fast-paced healthcare environment, this is your opportunity to make a real difference.


Key Responsibilities:

  • Independently develop and review content for protocols, CSRs, IBs, ICFs, and lay summaries

  • Create and revise regulatory documents for global filings (Modules 2, 4, 5 of eCTD; ACTD/CTD/NeeS formats)

  • Conduct literature searches and ensure accurate, consistent data integration

  • Review junior writers’ content and validate data authenticity

  • Maintain high-quality standards, data security, and regulatory compliance

  • Provide feedback, participate in client meetings, and support training initiatives

  • Contribute to process improvements and continuous learning initiatives


Required Skills & Qualifications:

  • MBBS, PhD, MDS, BDS, MPharm, PharmD, BPharm, or MSc

  • 4 to 6 years of experience in regulatory medical writing

  • Proven expertise in CTD Modules 2, 4, and 5, ACTD documentation

  • Excellent written and verbal communication

  • Strong knowledge of regulatory guidelines, clinical trial processes

  • Proficient with MS Office, especially Excel and PowerPoint

  • Familiarity with quality control procedures, referencing, and copyright norms


Perks & Benefits:

  • Fast-track global career growth opportunities

  • Exposure to both healthcare and technology industries

  • Work in a purpose-driven, innovation-led organization

  • Flexible hybrid work model (Bangalore office-based)

  • Inclusive and diverse work environment


About Indegene:

Indegene is a global healthcare solutions provider at the intersection of healthcare and technology. With a strong focus on medical, regulatory, and digital transformation services, Indegene empowers life sciences companies to be future-ready while offering accelerated global career opportunities.


Work Mode:

Hybrid (Office-based in Bangalore, KA)


Call to Action:

Are you ready to step into a strategic role in regulatory medical writing?
Apply now to join Indegene and fast-track your scientific writing career in a future-focused healthcare-tech organization.