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.
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