Senior Medical Writer

PRA; France; Sur place; EUR 50 000 - 75 000; Plein temps

Résumé du poste

A leading clinical research organization seeks a Senior Medical Writer to support a top pharmaceutical company. The role involves producing high-quality regulatory documents, collaborating with study teams, and ensuring submission readiness. Ideal candidates will have a strong writing background and experience in the pharmaceutical industry.

Qualifications

• 3-5 years of Medical Writing or relevant pharmaceutical experience.
• Proficiency in writing clinical/regulatory documents (CSRs, Protocols).
• Ability to convert scientific data into clear messages.

Responsabilités

• Produce clinical and regulatory documents in collaboration with Principal Medical Writers.
• Analyze data to determine the best writing approach.
• Facilitate document review, ensuring submission readiness.

Connaissances

Strong writing skills

Analytical skills

Regulatory knowledge

Scientific data interpretation

Formation

Bachelor’s degree

Master’s degree

Description du poste

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Senior Medical Writer Role

You will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Supporting a Top-5 pharma company, you will help deliver best-in-class regulatory and submission documents. While employed with ICON, you will be fully embedded with our client.

Responsibilities:

• Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers, including Clinical Study Protocols and Clinical Study Reports across Phase 1 to Phase 3 in multiple therapeutic areas.
• Analyze and interpret data critically to determine the best approach for each document, applying lean writing strategies.
• Act as the primary contact for the study team regarding document preparation and timelines, including planning.
• Facilitate document review, ensuring documents are submission-ready and approved, working directly with QC personnel and publishing specialists.

Minimum Requirements:

• Bachelor’s degree required; Master’s degree preferred.
• 3-5 years of Medical Writing or relevant pharmaceutical experience with scientific and regulatory knowledge.
• Strong writing skills with the ability to convert scientific data into clear, well-structured messages.
• Proficiency in independently writing clinical/regulatory documents (mainly CSRs, Protocols), leading creation, coordination, review facilitation, and ensuring submission readiness.