Principal Medical Writer

2+ 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

Position Title: Principal Medical Writer
Site Name: Bengaluru Luxor North Tower
Posted Date: Dec 17, 2024
Location: Bengaluru, India
Years of Experience: 10 - 12 years

Job Purpose:

The Principal Medical Writer is an expert contributor capable of independently executing complex writing assignments. This role requires a thorough understanding of clinical trial designs, the interpretation of statistically analyzed research data, and the ability to draft, review, and approve written assignments, including marketing application submission documents. You will be expected to plan and prioritize tasks without supervision, contribute to continuous improvement, and implement best practices in clinical document writing.

Key Responsibilities:

Clinical Regulatory Documents: Write clinical regulatory documents including protocols, clinical study reports (CSRs), NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
Cross-functional Collaboration: Work within a matrix team to ensure delivery of high-quality clinical documents that reflect data accurately and adhere to GSK standards and regulatory requirements.
Clinical Dossier Planning: Lead planning and production of clinical dossier documents for regulatory submissions worldwide.
Project Management: Manage increasingly complex projects and contribute to the assessment of scientific, operational, and submission development issues.
Data Interpretation & Writing: Analyze clinical data and effectively organize content and messages for clinical reports, summary documents, and tables.
Review & Automation: Provide input on the content and display of data in reports and explore tools and automation to expedite document preparation.
Leadership & Adaptability: Demonstrate leadership and adjust priorities based on a changing environment, including working across different therapeutic areas.

Education & Experience Requirements:

Educational Background: PhD or relevant working experience within the life sciences space.
Professional Experience: 10 - 12 years of experience in clinical regulatory writing in the pharmaceutical industry, including leadership roles.
Multicultural Experience: Experience working in multicultural settings, especially in global teams.
Regulatory Knowledge: Strong knowledge of ICH/GCP guidelines and clinical data interpretation.
Technical Skills: Advanced statistical and computer skills; proficiency in interpreting complex clinical data.
Language Skills: Excellent written and verbal communication skills in English.

Why GSK?

GSK is a global biopharma company committed to improving the health of billions of people worldwide. We focus on prevention, treatment of diseases, and advancing research in areas like oncology, HIV, respiratory, immunology, and infectious diseases. GSK aims to be a place where people feel welcome, valued, and included. We offer an environment where employees can thrive, grow, and take care of their well-being.

How to Apply:

Interested candidates can apply through the official GSK portal. GSK does not accept referrals from employment businesses or agencies without prior authorization.

Important Notice:
GSK does not charge any fee for recruitment processes. Please be cautious of any fraudulent job offers or emails claiming to be from GSK, especially those asking for payments or offering fake opportunities. If you encounter any suspicious activity, contact us at askus@gsk.com.

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Principal Medical Writer

Job Description

Job Purpose:

Key Responsibilities:

Education & Experience Requirements:

Why GSK?

How to Apply:

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