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Nt- Associate Manager - Scientific Writing

10-12 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

 

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.