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Principal Medical Writer

0-5 years
Not Disclosed
10 Aug. 6, 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, 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 Opportunity at GSK: Clinical Regulatory Document Specialist

Location: Bengaluru Luxor North Tower
Posted Date: July 16, 2024

Key Responsibilities

  • Clinical Document Writing: Proven track record in writing a variety of clinical regulatory documents, including protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
  • Matrix Team Collaboration: Work effectively within a matrix team to produce high-quality clinical documents that accurately reflect associated data and comply with GSK standards and global, regional, and local regulatory requirements.
  • Regulatory Submissions: Significant experience in the planning and production of clinical dossier documents for regulatory submissions worldwide.
  • Project Management: Demonstrated effectiveness in managing projects of increasing scope and complexity.
  • Functional Understanding: Deep understanding of interdependencies among various functions such as clinical pharmacology, biomarkers, and health outcomes.
  • Complex Problem-Solving: Ability to quickly assess complex situations, apply scientific and operational knowledge, and develop effective solutions.
  • Technical Skills: High-level technical, statistical, and computer skills with the ability to interpret complex clinical data.
  • Content Organization: Ability to assess trends and patterns in text and statistical data, and organize content and messages effectively in clinical reports and summary documents.
  • Review and Input: Review reporting and analysis plans, and provide critical input on content and presentation of tables.
  • Document Preparation: Familiarity with methods to expedite document preparation, including review tools and automation.
  • Adaptability: Demonstrated ability to adjust behaviors and priorities based on a changing environment and support documents in various therapeutic areas.
  • Communication Skills: Strong effectiveness in both oral and written communications.

Why Join GSK?

At GSK, we unite science, technology, and talent to advance health and tackle disease. As a global biopharma company, we are dedicated to making a positive impact on the health of billions of people while delivering strong, sustainable returns for shareholders. Our focus spans vaccines, specialty and general medicines, with core therapeutic areas including infectious diseases, HIV, respiratory/immunology, and oncology.

We believe that our success is driven by our people. We strive to create an inspiring, inclusive, and growth-oriented environment where everyone feels welcome and valued. Join us to be part of a collaborative team that is dedicated to getting ahead of disease together and thriving in your career.

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Apply today and be part of GSK's mission to make a global impact!