Principal Medical Writer

Gsk Plc

10-12 years

Not Disclosed

Bengaluru

10 Dec. 24, 2024

Job Description

Job Type: Full Time Education: MSc./M. Pharm/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: Principal Medical Writer
Location: Bengaluru Luxor North Tower
Posted Date: December 17, 2024
Experience Required: 10-12 years

Role Overview:

The Principal Medical Writer is a key expert contributor responsible for independently executing complex writing assignments. This includes a deep understanding of clinical trial designs and the interpretation of statistically analyzed data. The role involves drafting, reviewing, and approving clinical regulatory documents including marketing application submissions.

Key Responsibilities:

Clinical Document Writing: Develop clinical regulatory documents such as protocols, clinical study reports (CSR), NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
Collaboration: Work in matrix teams to ensure the delivery of high-quality clinical documents that accurately reflect data and comply with GSK standards and regulatory requirements.
Project Management: Contribute to the planning and production of clinical dossier documents for global regulatory submissions.
Analysis and Interpretation: Apply scientific and statistical knowledge to interpret clinical data, assess trends, and organize complex content effectively in clinical reports.
Continuous Improvement: Support continuous improvement and implementation of best practices in clinical documentation and writing.
Cross-functional Coordination: Work with clinical pharmacology, biomarkers, health outcomes, and other functions to understand interdependencies in document creation.
Document Preparation: Utilize review tools and automation to expedite document preparation, ensuring compliance and quality.

Education and Experience Requirements:

Education: PhD or equivalent working experience within the life sciences field.
Experience: 10-12 years of clinical regulatory writing experience in the pharmaceutical industry, with expertise in writing high-level clinical and regulatory documents.
Leadership: Demonstrated leadership and ability to manage projects with increasing scope and complexity.
Technical Skills: High-level proficiency in technical, statistical, and computer skills. Ability to interpret and analyze clinical data.
Regulatory Knowledge: Familiarity with ICH/GCP guidelines and global/regional/local regulatory requirements.
Languages: Excellent verbal and written communication skills in English.

Why GSK?

GSK is a global biopharma company united by a common purpose: to get ahead of disease together. We innovate with science, technology, and talent to improve the lives of millions worldwide. As part of GSK, you will thrive in a culture that celebrates diversity and inclusion, values continuous learning, and fosters personal and professional growth.

Additional Information:

Employment Type: Full-time
Location: Bengaluru, India

Important Notices:

No Recruitment Fees: GSK does not charge any recruitment fees and is not responsible for any fraudulent job advertisements.
Avoid Scams: Be cautious of unsolicited emails or job ads. Always verify the authenticity of recruitment communications through GSK's official channels.

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