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Senior Medical Writer

3-5 years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

About the Role

Senior Medical Writer
Join the world's largest and most comprehensive clinical research organization, driven by healthcare intelligence. In this role, you will be supporting a top-5 pharmaceutical company, helping them deliver best-in-class regulatory and submission documents. While employed by ICON, you will work directly with our client, fully embedded in their team.


Responsibilities

  • Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers. Documents may include clinical study-level documents such as Clinical Study Protocols or Clinical Study Reports, spanning Phase 1 to Phase 3 across multiple therapeutic areas.

  • Thoroughly analyze and interpret data to determine the best approach for composing each document, applying lean writing strategies.

  • Serve as the primary point of contact for the study team regarding the preparation and timelines (including planning) of assigned documents.

  • Facilitate the document review process, ensuring that documents are submission-ready and receive final approval. Work closely with QC personnel and publishing specialists to support document preparation.

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Your Profile

  • Education: Minimum of a Bachelor’s degree (Master’s degree preferred).

  • Experience: 3-5 years of Medical Writing experience or other relevant pharmaceutical experience, combined with scientific and regulatory knowledge.

  • Skills:

    • Strong writing skills with the ability to convert complex scientific data into clear, scientifically sound, and well-structured messages.

    • Proficient in independently writing clinical and regulatory documents, especially Clinical Study Reports (CSRs) and Protocols.

    • Experience in leading the creation and coordination of authoring functions, facilitating document reviews, and ensuring submission-ready documents are finalized and approved.


This role provides an excellent opportunity to make a meaningful impact in clinical research and regulatory submission processes while being part of a world-class team at ICON.