Associate Manager - Scientific Writing (Bangalore, India)
Job Summary
Join a global healthcare leader as an Associate Manager - Scientific Writing, where you will lead and manage complex clinical and regulatory medical writing projects, support global submissions (CTD Modules 2 and 5), mentor junior writers, and ensure compliance with international pharmaceutical documentation standards. If you're a scientific communicator with 10+ years of experience in regulatory documentation and strong leadership capabilities, this full-time Bangalore-based role is ideal for you.
Key Responsibilities
Independently author and review CSRs, protocols, amendments, IBs, ICFs, and CTD Modules 2.4–2.7 and 5.2
Lead document planning, review cycles, and finalization under tight timelines
Apply lean authoring and structured content principles
Manage project and team work plans and timelines
Train and supervise junior writers
Conduct literature reviews and ensure scientific accuracy
Align messaging across regulatory documents for consistency
Ensure compliance with regulatory and organizational SOPs
Facilitate meetings, manage stakeholder feedback, and ensure document quality
Required Skills and Qualifications
Education: MBBS, PhD, MDS, BDS, MPharm, or PharmD
Experience: 10 to 12 years in clinical and regulatory medical writing (global filings)
Strong experience in Module 2 and 5 documents, CSRs, protocols, and IBs
Understanding of global regulatory guidelines (US FDA, EMA, ICH)
Familiarity with structured content management and lean authoring
Proficiency in MS Word, document systems, and Word add-ins
Ability to interpret clinical data and write with scientific accuracy
Minimum 2 years of people management experience
Broad therapeutic area knowledge is an advantage
Excellent written and verbal communication skills
Perks and Benefits
Competitive salary package
Leadership opportunity in a global pharmaceutical environment
Exposure to global regulatory submissions and cross-functional teams
Learning and development opportunities
Collaborative work culture
Opportunities to mentor and coach junior writers
Company Overview
Join one of the world’s leading clinical research organizations, known for excellence in regulatory writing, clinical trial management, and global drug development support. The organization is committed to advancing healthcare through innovation and collaboration.
Work Mode
On-site — Bangalore, India
Call-to-Action
Are you a seasoned scientific writer ready to lead critical regulatory projects and grow your career? Apply now to become a vital contributor to global pharmaceutical development.
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