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Senior Medical Writer

3-5 years
Not Disclosed
10 Dec. 6, 2024
Job Description
Job Type: Remote 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

Senior Medical Writer
Location: Remote
Company: ICON plc

Role Overview

ICON is looking for a Senior Medical Writer to join the world’s largest and most comprehensive clinical research organization, supporting a Top-5 pharmaceutical company. This is an exciting opportunity to contribute to the delivery of high-quality regulatory and submission documents, embedded with the client while being employed by ICON.

Key Responsibilities

  • Clinical & Regulatory Document Production:

    • Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers, including Clinical Study Protocols (CSPs) and Clinical Study Reports (CSRs), across Phase 1 to Phase 3 therapeutic areas.

    • Analyze and interpret data to develop clear, scientifically sound documents, applying lean writing strategies.

    • Serve as the primary contact for the study team regarding preparation, timelines, and planning of assigned documents.

    • Facilitate the review process to ensure documents are submission-ready and meet regulatory standards, collaborating with QC personnel and publishing specialists during document preparation.

Qualifications & Experience

  • Education:

    • Minimum of a bachelor’s degree (Master’s degree preferred).

  • Experience:

    • 3-5 years of experience in medical writing or other relevant pharmaceutical experience, with a solid understanding of scientific and regulatory knowledge.

    • Strong writing skills with the ability to clearly translate scientific data into structured, well-organized messages.

    • Experience in writing and coordinating clinical and regulatory documents, particularly CSRs and Protocols, ensuring they are finalized and ready for submission.

Skills:

  • Proficiency in writing clinical documents independently.

  • Strong communication and collaboration skills, particularly in coordinating authoring functions and ensuring timely reviews and approvals.

  • Ability to work effectively with QC personnel and publishing specialists.

Benefits

  • ICON offers a competitive salary and benefits package, supporting your career growth and well-being.

  • Flexible work options, including remote work, to promote work-life balance.

Why ICON?
ICON is a leading provider of healthcare intelligence and clinical research services. With a focus on professional development, we offer employees opportunities for continued learning and career advancement in a supportive and inclusive environment.

Interested? Apply today to become part of a world-class organization dedicated to advancing healthcare and regulatory excellence.