Senior Medical Writer

5+ years

Not Disclosed

Bengaluru

10 Jan. 6, 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

Job Title: Senior Medical Writer
Location: Bengaluru Luxor North Tower
Posted Date: January 4, 2025
Experience Required: 6–9 years

Job Purpose

As a Senior Medical Writer at GSK, you will independently handle a variety of complex clinical and regulatory writing assignments. This includes authoring high-quality documents for clinical trials and regulatory submissions, ensuring compliance with internal standards and global regulations. You will collaborate with cross-functional teams, driving excellence in content development, quality, and delivery.

Key Responsibilities

Document Development:
- Independently author clinical and regulatory documents, including protocols, clinical study reports (CSRs), NDA/MAA CTD submissions, investigator brochures, briefing documents, and responses to regulatory authority questions.
Quality and Consistency:
- Ensure integrity and accuracy in data interpretation.
- Maintain high-quality standards and consistency in all documents.
Stakeholder Collaboration:
- Actively participate in planning, coordination, and review meetings.
- Build and maintain partnerships with Clinical Leads, Asset Leads, Study Delivery Leads, Biostatisticians, and other Medical Writers.
Project Management:
- Work on 2–3 assignments simultaneously, adhering to timelines and prioritizing tasks.
- Raise concerns or propose alternatives to address issues in a proactive and timely manner.
Guidance and Mentorship:
- Serve as a mentor for less experienced team members, fostering high medical writing standards.

Education Requirements

PhD or equivalent expertise (e.g., Master’s degree with a minimum of 2 years of relevant experience).

Job-Related Experience

Up to 5 years of clinical regulatory writing experience in the pharmaceutical industry.
Strong understanding of drug development and clinical trial design.
Expertise in interpreting, describing, and documenting clinical data.
Knowledge of International Committee for Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines.
Proficiency in medical terminology, scientific methodology, and statistical principles.
Excellent English language skills (verbal and written).
Advanced computer literacy and familiarity with regulatory writing tools.

Why GSK?

At GSK, our mission is to unite science, technology, and talent to stay ahead of disease and improve health outcomes globally. We’re focused on developing innovative vaccines, specialty medicines, and general healthcare solutions in our core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.

Our people are the cornerstone of our success. GSK is committed to being a place where everyone can thrive, feel included, and grow. We foster a culture that values collaboration, diversity, and the unique perspectives of our team members.

Important Notices

GSK does not charge any fees during the recruitment process.
If you encounter unsolicited communications or job advertisements requesting payments, please report them to askus@gsk.com.
GSK requires employment businesses/agencies to secure prior written authorization before referring candidates for posted vacancies.

Ready to thrive in a role that makes a difference? Join us at GSK and get ahead together!

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Senior Medical Writer

Job Description

Job Purpose

Key Responsibilities

Education Requirements

Job-Related Experience

Why GSK?

Important Notices

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