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Senior Medical Writer

TN France

France

Sur place

EUR 45 000 - 70 000

Plein temps

Il y a 20 jours

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Résumé du poste

An established industry player is seeking a Senior Medical Writer to support a top-tier pharmaceutical company. In this pivotal role, you will independently create clinical and regulatory documents, ensuring they are submission-ready and meet the highest standards. Your expertise in medical writing and regulatory knowledge will be crucial as you analyze and interpret complex data, facilitating reviews and coordinating with various stakeholders. This position promises stable employment and the opportunity to make a significant impact in the clinical research field.

Qualifications

  • 3-5 years of Medical Writing or relevant pharmaceutical experience.
  • Strong writing skills to convert scientific data into clear messages.

Responsabilités

  • Produce clinical and regulatory documents in collaboration with Principal Medical Writers.
  • Act as the primary contact for the study team regarding document preparation.

Connaissances

Medical Writing
Regulatory Knowledge
Data Analysis
Lean Writing Strategies
Strong Writing Skills

Formation

Bachelor’s Degree
Master’s Degree

Description du poste

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Senior Medical Writer

Join the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Support a Top-5 pharma company by delivering best-in-class regulatory and submission documents. Enjoy stable employment with ICON, fully embedded with our client.

Responsibilities:
  1. 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.
  2. Analyze and interpret data critically to determine the best approach for each document, applying lean writing strategies.
  3. Act as the primary contact for the study team regarding preparation and timelines of assigned documents.
  4. Facilitate review processes, ensuring documents are submission-ready and approved, working closely 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, capable of converting scientific data into clear, well-structured messages.
  • Proven ability to independently write various clinical/regulatory documents (mainly CSRs, Protocols), coordinate authoring, facilitate reviews, and ensure submission readiness.
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