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Principal Medical Writer

10-12 years
Not Disclosed
10 Dec. 19, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Principal Medical Writer
Location: Bengaluru Luxor North Tower, Bengaluru
Posted Date: Dec 17, 2024
Experience: 10 - 12 years

Job Purpose:
The Principal Medical Writer will be an expert contributor, independently executing complex writing assignments with a deep understanding of clinical trial designs and the interpretation of statistically analyzed research data. This individual will coordinate and drive the drafting, review, and approval of written materials, including regulatory submission documents. The role requires extensive clinical document expertise and the ability to plan and prioritize work independently, ensuring continuous improvement and adherence to best practices.

Key Responsibilities:

  • Write clinical regulatory documents including protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
  • Collaborate within a matrix team to ensure delivery of high-quality clinical documents that align with GSK standards and global/regional/local regulatory requirements.
  • Contribute significantly to the planning and production of clinical dossier documents for global regulatory submissions.
  • Manage projects of increasing scope and complexity, implementing effective plans for solutions.
  • Demonstrate high-level technical, statistical, and computer skills to interpret complex clinical data.
  • Analyze trends and patterns in text and statistical data, organizing content effectively in clinical reports and summary documents.
  • Review reporting and analysis plans, providing input on content and table display.
  • Utilize tools and automation approaches to expedite document preparation.
  • Adapt to changing priorities, supporting documents across various therapeutic areas.
  • Demonstrate effective oral and written communication skills in all aspects of the role.

Education and Experience Requirements:

  • Education: PhD or relevant experience in life sciences.
  • Experience:
    • Significant experience in clinical regulatory writing within the pharmaceutical industry.
    • Leadership experience in managing cross-functional projects.
    • Familiarity with ICH/Good Clinical Practice (GCP) guidelines.
    • Experience working in multicultural settings and remote teams.
    • Strong interpretation and documentation skills for clinical data.
    • Excellent English language skills (verbal and written).

Why GSK?
At GSK, we unite science, technology, and talent to get ahead of disease together. Our success depends on our people, and we foster an environment where individuals are inspired, challenged, and valued. We focus on delivering results, continuously learning, and building collaborative relationships. If you share our ambition and values, we invite you to join us on this exciting journey.

Important Notice:
GSK does not accept referrals from employment agencies without prior written authorization. Any unsolicited job applications or emails asking for payments for recruitment are fraudulent. GSK does not charge any fee during the recruitment process.