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Senior Associate - Scientific Writing Date: 7 Jun 2025

4-6 years
Not Disclosed
10 June 13, 2025
Job Description
Job Type: Full Time Education: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/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 at Indegene, Bangalore (Hybrid)

Job Summary

Indegene, a leading healthcare solutions provider at the intersection of technology and healthcare, is hiring a Senior Associate - Scientific Writing in Bangalore. This role demands strong regulatory writing skills with 4 to 6 years of experience in authoring and reviewing clinical and non-clinical regulatory documents under CTD/ACTD formats. If you are looking to advance your career in a fast-paced, global healthcare environment, this opportunity is for you.


Key Responsibilities

  • Develop, review, and ensure quality of regulatory documents like Protocols, CSRs, IBs, ICFs, and Lay Summaries.

  • Conduct literature searches and review scientific articles to extract relevant information.

  • Adhere to global regulatory dossier formats (eCTD, ACTD, NeeS).

  • Perform quality checks on data accuracy and document consistency.

  • Mentor and guide junior team members in content development and review.

  • Ensure adherence to company and client-specific quality and compliance guidelines.

  • Participate in client and internal meetings to ensure smooth project execution.

  • Contribute to training, continuous learning, and process improvement initiatives.


Required Skills & Qualifications

  • Education: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/MSc.

  • Experience: 4 to 6 years of regulatory writing and review experience.

  • Strong knowledge of clinical trial processes and product lifecycle.

  • Expertise in Module 2, 4, and 5 of eCTD, and ACTD formats.

  • Proficiency in MS Office (Excel, PowerPoint).

  • Excellent written and verbal communication skills.

  • Ability to guide and mentor junior writers.

  • Familiarity with quality standards, data privacy, and security norms (ISMS, ISO, CMMI).


Perks & Benefits

  • Opportunity to work in a rapidly growing global healthcare tech organization.

  • Exposure to international regulatory standards and guidelines.

  • Hybrid work model for better work-life balance.

  • Fast-track career growth with leadership and mentorship opportunities.

  • Inclusive, diverse, and collaborative workplace environment.


Company Description

Indegene is a technology-led global healthcare solutions company specializing in regulatory writing, scientific content development, and technology-driven healthcare services. It offers accelerated career growth for ambitious professionals at the convergence of healthcare and technology.


Work Mode

Hybrid (Bangalore Office)


Call-to-Action

Ready to take the next step in your scientific writing career? Apply now and become part of Indegene's dynamic and innovative healthcare team.