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Cmc Technical Writer – France

5+ years
Not Disclosed
10 Feb. 10, 2025
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

CMC Technical Writer – France (Full-Time, Permanent)

Excelya | Full-Time | Permanent | France

Excelya, a leading Contract Research Organization (CRO) in Europe, is seeking a CMC Technical Writer to support regulatory submissions for late-stage clinical applications and marketing authorizations. This role involves collaborating with cross-functional teams to ensure high-quality, compliant documentation for regulatory authorities.

Key Responsibilities

  • Prepare, review, and finalize regulatory submission documents for Phase 3 clinical trials and marketing applications.
  • Author CMC sections (Modules 2.3 and 3 of the CTD) for regulatory submissions, including briefing documents for Health Authority consultations.
  • Work closely with CMC teams (formulation, process development, analytical, and manufacturing) to compile data for regulatory submissions.
  • Maintain and update CMC regulatory dossier templates to ensure compliance with evolving regulatory guidelines.
  • Collaborate with Regulatory Submission Managers to manage CMC regulatory submission workflows.
  • Ensure accuracy, consistency, and completeness of narratives within regulatory documents.
  • Oversee timelines and deliverables for multiple projects, ensuring timely submissions.

Minimum Requirements

  • Degree in Pharmacy, Chemistry, Biology, or a related scientific field.
  • 5+ years of experience in a CMC role within the pharmaceutical industry, with at least 3 years in CMC regulatory submission technical writing.
  • Strong knowledge of CMC-related regulatory requirements (e.g., ICH, FDA, EMA) and experience with eCTD submissions.
  • Excellent technical writing skills with the ability to convey complex scientific concepts clearly.
  • Attention to detail and high accuracy in regulatory documentation.
  • Strong interpersonal, communication, and project management skills.
  • Proficiency in MS Office and regulatory information management software (e.g., eCTD, Veeva).
  • Fluent in written and spoken English.

This role offers an opportunity to work in a dynamic, team-oriented environment while contributing to Excelya’s mission of advancing regulatory compliance and clinical research.