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Nt -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, or PharmD 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)

Job Summary

Indegene is hiring a Senior Associate – Scientific Writing to support global clinical and regulatory documentation efforts. This role is ideal for candidates with 4–6 years of experience in regulatory writing, especially with CTD Modules 2 and 5, clinical study reports (CSRs), protocols, and investigator brochures. The selected candidate will be responsible for authoring and reviewing documents, mentoring junior writers, and collaborating with cross-functional teams in a fast-paced healthcare technology environment.


Key Responsibilities

  • Independently author and review CSRs, protocols, amendments, IBs, and CTD summaries

  • Apply lean authoring and structured content principles for document development

  • Coordinate activities for document review, consensus meetings, QC, and finalization

  • Ensure adherence to templates, regulatory standards, and sponsor requirements

  • Manage document timelines and team roles to meet milestone deliverables

  • Lead kickoff meetings and maintain open communication within cross-functional teams

  • Conduct literature reviews and data interpretation for content accuracy

  • Mentor and train junior writers

  • Contribute to department initiatives and share best practices


Required Skills & Qualifications

  • Education: MBBS, PhD, MDS, BDS, MPharm, or PharmD

  • Experience: 4–6 years in regulatory and clinical document writing

  • Strong experience in CTD Modules 2.4–2.7, 5.2, CSRs, protocols, IBs, and amendments

  • Knowledge of ICH-GCP, FDA, EMA, and global regulatory writing standards

  • Experience with document management systems and structured content tools

  • Ability to lead document teams and manage authoring timelines

  • Excellent written communication, data interpretation, and teamwork skills

  • Comfortable working independently while coordinating with sponsors

  • Proficiency in MS Word and working with templates and add-ins


Technology & Tools (Good to Have)

  • MS Word (advanced features)

  • Document management platforms and eApproval systems

  • Familiarity with Word add-ins for formatting, references, and styles

  • Flexibility to learn and adapt to new writing technologies


Perks & Benefits

  • Opportunity to work at the intersection of healthcare and technology

  • Exposure to global regulatory submissions and therapeutic areas

  • Entrepreneurial and fast-paced work culture

  • Structured mentorship and professional development

  • Inclusive and diverse workplace

  • Equal employment opportunity and merit-based career advancement


Company Overview

Indegene is a global healthcare solutions provider combining deep domain expertise with leading-edge technology to transform the future of healthcare. Known for its strong presence in medical writing, RWE, and regulatory services, Indegene empowers pharmaceutical organizations to be agile, efficient, and compliant in a rapidly evolving industry.


Work Mode

On-site – Bangalore, India


Compensation Range

Not explicitly mentioned in the job description. Compensation will be competitive and based on experience and qualifications.


Call to Action

Ready to accelerate your career in regulatory medical writing with one of the most dynamic healthcare technology companies? Apply now and become a critical part of Indegene’s high-impact writing team supporting global pharmaceutical innovation.