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Senior Medical Writer

Gsk Plc
GSK plc
5+ years
Not Disclosed
10 Feb. 4, 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

Here’s your refined version with a unique slug at the end:

Senior Medical Writer – Bengaluru, India (senior-medical-writer-bengaluru-414161)

Location: Bengaluru, India
Department: Medical and Clinical
Job ID: 414161
Experience: 6 - 9 years
Work Location: Bengaluru

Job Purpose:

The Senior Medical Writer will work on clinical and regulatory documents independently or, for complex assignments, under mentor guidance. The role requires proactive coordination with stakeholders to ensure high-quality medical writing aligned with global standards.

Key Responsibilities:

  • Author clinical and regulatory documents, including protocols, clinical study reports (CSR), investigator brochures, briefing documents, and regulatory submission materials (e.g., m2.5, m2.7.1, m2.7.2).
  • Maintain data integrity and ensure consistent, high-quality documentation.
  • Participate in planning, coordination, and review meetings.
  • Handle 2-3 assignments simultaneously while ensuring timely and accurate deliverables.
  • Engage with cross-functional teams, including Clinical Leads, Biostatisticians, and Study Delivery Leads.
  • Ensure adherence to ICH-GCP guidelines and industry best practices.

Education & Experience Requirements:

  • PhD or equivalent expertise (Master’s degree with at least 2 years of relevant experience).
  • Up to 5 years of clinical regulatory writing experience in the pharmaceutical industry.
  • Strong understanding of clinical trial design, data interpretation, and statistical principles.
  • Proficiency in electronic documentation systems and excellent English language skills (verbal and written).

Why GSK?

GSK is a global biopharma leader focused on uniting science, technology, and talent to advance healthcare worldwide. We prioritize innovation and diversity while offering an inclusive work environment where employees thrive.

Diversity & Inclusion at GSK:

GSK is an equal opportunity employer that values diverse perspectives and fosters an inclusive culture. We do not charge fees during the recruitment process. If you encounter fraudulent job postings, report them to askus@gsk.com.

Apply now and be part of GSK’s mission to get ahead of disease together!