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Senior Medical Writer

6-9 years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: PhD 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 Medical Writer | GSK – Bengaluru, India

💼 Company: GSK
📍 Location: Bengaluru Luxor North Tower, Bengaluru, India
🕒 Job Type: Full-Time
🌍 Category: Medical and Clinical

About GSK

GSK is a global biopharmaceutical company committed to advancing healthcare by uniting science, technology, and talent to get ahead of disease. They focus on preventing and treating diseases with vaccines and specialty medicines across four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology. GSK is dedicated to fostering an inclusive and diverse workplace that drives innovation and growth.

Role Overview

The Senior Medical Writer is responsible for creating high-quality clinical documents, such as regulatory documents, clinical study reports, and submissions for New Drug Applications (NDA) and Marketing Authorization Applications (MAA). The writer will work independently on assignments and collaborate with cross-functional teams to ensure all deliverables meet global quality standards.

Key Responsibilities

  • Independently author clinical documents, including protocols, clinical study reports, investigator brochures, and NDA/MAA submission documents.
  • Ensure high integrity of data interpretation and maintain consistency across documents.
  • Participate actively in planning, coordination, and review meetings.
  • Work simultaneously on 2-3 assignments and ensure timely completion.
  • Raise concerns or issues proactively and promote high medical writing standards within the team.
  • Collaborate with Clinical Leads, Asset Leads, Biostatisticians, and other teams to deliver quality writing.

Candidate Requirements

🎓 Education & Experience:

  • PhD or equivalent expertise (Master's with a minimum of 2 years relevant experience).
  • Up to 5 years of clinical regulatory writing experience in the pharmaceutical industry.
  • Strong understanding of drug development and scientific methodology.
  • Knowledge of ICH/GCP guidelines and the ability to interpret clinical data.

💼 Skills:

  • Excellent English language skills (verbal and written).
  • Proficiency in clinical and regulatory document writing.
  • Ability to collaborate with a diverse range of teams and stakeholders.
  • Strong attention to detail and ability to manage multiple assignments.

Why GSK?

GSK offers an inspiring work environment that values inclusivity, personal growth, and well-being. Employees are encouraged to thrive in an organization that fosters a culture of collaboration and excellence. GSK’s mission to impact global health is supported by its commitment to innovation, making it an exciting time to join the company.

How to Apply

Interested candidates can apply directly on the GSK website.