Principal Medical Writer

Gsk Plc

12-16 years

25-40 LPA

Bengaluru

1 Dec. 2, 2025

Job Description

Job Type: Full Time Education: B.Pharm, M.Pharm, Pharm D., BSc., MSc., Lifesciences graduate 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

Principal Medical Writer

GSK | Bengaluru, India

Location: Bengaluru, India
Department: Medical and Clinical
Employment Type: Full-Time
Experience Required: Minimum 7 years
Estimated Salary Range: ₹25,00,000 – ₹40,00,000 per annum (based on industry benchmarks & seniority)
Job ID: 431165
Posted On: 28 November 2025

About GSK

GSK is a global biopharmaceutical organization committed to uniting science, technology, and exceptional talent to get ahead of disease. With a mission to impact the health of 2.5 billion people by the end of the decade, GSK focuses on developing innovative vaccines and specialty medicines across key therapeutic areas, including respiratory, oncology, immunology, infectious diseases, and HIV.
The company fosters a culture built on accountability, scientific excellence, integrity, and patient-centric innovation.

Role Overview

The Principal Medical Writer is a senior expert role responsible for independently leading the development of complex safety and clinical documents. This position requires deep experience in safety writing, sophisticated data interpretation, and cross-functional collaboration to support regulatory submissions and global safety deliverables.
The role plays a critical part in enabling high-quality, compliant, and scientifically robust safety documentation across GSK’s R&D portfolio.

Key Responsibilities

Lead the preparation of advanced safety and clinical documents, including DSURs, PSURs/PBRERs, RMPs, ACOs, and US regulatory reports (PADERs/PAERs).
Oversee content development by co-authors and ensure the quality and accuracy of all contributions.
Drive cross-functional collaboration across safety, regulatory, clinical, epidemiology, statistics, and programming functions.
Develop and execute document strategy, review cycles, and project timelines.
Interpret complex clinical and statistical data to create clear, accurate, and compliant safety documents.
Anticipate challenges, assess emerging issues, and deliver data-driven solutions.
Mentor junior writers and contribute to capability-building initiatives.
Utilize automation platforms, authoring tools, and modern document management systems.
Lead process improvement initiatives to strengthen medical writing quality and efficiency.
Support vendor oversight and ensure alignment with GSK standards and regulatory expectations.

Education Requirements

Master’s degree or equivalent in a scientific discipline.
Degrees in Medicine, Dentistry, Physiotherapy, or Experimental Medicine are an advantage.

Experience Requirements

Minimum 7 years of advanced safety writing experience in the pharmaceutical domain.
Strong expertise in interpreting complex clinical, safety, and statistical data.
Working knowledge of ICH, GVP, FDA, EMA, and other regulatory guidelines.
Experience across multiple therapeutic areas.
Proven ability to independently author high-impact, complex regulatory documents.

Skills and Competencies

Advanced expertise in safety writing and regulatory documentation.
Strong leadership capabilities, especially in matrix environments.
Ability to manage multiple high-priority projects simultaneously.
Excellent communication skills and high proficiency in written English.
Strong analytical thinking, content organization skills, and attention to detail.
Ability to work effectively across diverse, multicultural global teams.
Advanced computer literacy and familiarity with modern writing tools.

Why Work at GSK

Competitive base salary aligned with global standards.
Annual performance-based bonus.
Flexible working options for most roles.
Comprehensive learning and development pathways.
Access to healthcare and wellbeing programmes.
Strong employee recognition frameworks.
Inclusive and innovation-driven work culture.

How to Apply

Candidates may apply directly through the official GSK careers portal or follow the application instructions provided for this position.
For queries related to recruitment adjustments or accommodations, applicants may contact the GSK Recruitment Team at IN.recruitment-adjustments@gsk.com.

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Principal Medical Writer

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