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Senior Medical Information Writer

5+ years
Not Disclosed
10 April 23, 2025
Job Description
Job Type: Full Time Education: PharmD/PhD/M.Sc/MBBA 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

Senior Medical Information Writer
Location: Hyderabad, India

About the Job:
Join a growing, diverse portfolio where your contributions will support life-changing treatments for patients managing diabetes, cardiovascular disease, transplant complications, and immunological disorders. Powered by digital innovation and AI, we are expanding access faster than ever before. This is your opportunity to shape the future of healthcare and turn ambition into global impact.

Main Responsibilities:

  • Research and author scientific response documents under the direction of the Global Medical Information (GMI) team.

  • Conduct literature searches, review complex scientific data, and summarize findings.

  • Generate evidence-based, accurate, and fair-balanced scientific response documents for designated therapeutic areas.

  • Adapt global scientific response documents for assigned countries and develop responses to escalated inquiries.

  • Contribute to US NDA Annual Reports and US compendia reviews.

  • Build and maintain Therapeutic Area expertise and peer review scientific content.

  • Collaborate effectively with GMI teams to execute content plans and maintain high standards of deliverables.

People Responsibilities:

  • Maintain effective relationships with stakeholders in the medical and scientific communities for assigned global business units and products.

  • Engage with medical and pharmacovigilance teams to meet content development needs.

  • Mentor and support fellow medical information writers by sharing expertise and knowledge.

Performance Responsibilities:

  • Deliver scientific response documents, US NDA Annual Reports, and US compendia reviews in alignment with agreed timelines and quality standards.

Process Responsibilities:

  • Act as a subject matter expert in medical information writing and stay updated with regulatory requirements for supported countries.

  • Conduct comprehensive needs analyses and implement content plans accordingly.

  • Collaborate with selected vendors to ensure timely and quality deliverables.

  • Continuously improve course content and delivery based on feedback from end users.

Stakeholder Responsibilities:

  • Work closely with regional and area medical teams to identify needs and develop customized deliverables.

  • Liaise with the Medical department to produce relevant, tailored content for diverse audiences.

About You:

Experience:

  • Over 5 years of experience in medical writing within the pharmaceutical or healthcare industry, or relevant clinical experience.

  • Minimum 2-3 years direct experience in Medical Information roles within a pharmaceutical company.

Soft Skills:

  • Strong stakeholder management and communication skills.

  • Ability to work independently and collaboratively within a team.

Technical Skills:

  • Expertise in medical writing operational excellence, time and risk management, technical editing, literature evaluation, and multilevel response development.

Education:

  • Advanced degree in Life Sciences, Pharmacy, or related disciplines (e.g., PharmD, PhD, MSc, MBA, or equivalent).

Languages:

  • Excellent command of the English language, both spoken and written.