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Senior Medical Information Writer

2-3 years
Not Disclosed
10 Aug. 13, 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: Scientific Response Writer

Main Responsibilities:

  • Research and Documentation:
    • Conduct literature searches and reviews, extracting and summarizing complex data from scientific literature.
    • Create and maintain evidence-based, accurate, and balanced scientific response documents for products in designated therapeutic areas.
    • Adapt global scientific response documents for specific countries.
    • Develop responses to escalated inquiries from assigned countries.
    • Contribute to US NDA Annual Reports and US compendia reviews.
    • Develop and maintain expertise in relevant Therapeutic Areas.
    • Review content created by peer writers.
    • Collaborate with Global Medical Information teams to execute content plans.

People Management:

  • Stakeholder Engagement:
    • Maintain effective relationships with end stakeholders (Medical scientific community) within the allocated Global business unit and product.
    • Interact with stakeholders in medical and pharmacovigilance departments.
    • Support other medical information writers in developing their knowledge and sharing expertise.

Performance:

  • Deliverables:
    • Provide high-quality deliverables, including scientific response documents, US NDA Annual Reports, and US compendia reviews, within agreed timelines.

Process:

  • Expertise and Implementation:
    • Act as an expert in medical information writing and stay updated on regulatory requirements for supported countries.
    • Assist in conducting comprehensive medical writing needs analyses.
    • Implement relevant elements of content plans and associated activities for assigned countries.
    • Collaborate with selected vendors to deliver required deliverables according to defined processes.
    • Design action plans based on customer feedback to improve content and delivery.

Stakeholders:

  • Coordination:
    • Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing deliverables.
    • Liaise with the Medical department to prepare customized deliverables.

About You:

  • Experience:

    • Over 5 years of experience in medical writing within the pharmaceuticals or healthcare industry, or equivalent clinical experience.
    • At least 2-3 years of direct experience in medical information within a pharmaceutical company.
  • Soft Skills:

    • Effective stakeholder management and communication skills.
    • Ability to work independently and collaboratively within a team environment.
  • Technical Skills:

    • Expertise in medical operational excellence, time, and risk management.
    • Excellent technical (medical) editing and writing skills.
    • Knowledge of literature evaluation and multilevel response development.
  • Education:

    • Advanced degree in life sciences, pharmacy, or a similar discipline (e.g., PharmD, Ph.D., Master’s in Science, MBA, or equivalent).
  • Languages:

    • Excellent command of the English language (spoken and written).