Medical Writing Project Manager

  • Salary: Competitive
  • REF Number: 00054633
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 800 106 106
  • Date Published: 26.10.2022
  • Sector:
  • Location: Opfikon,
  • Discipline:

QLS are recruiting for a Medical Writing Project Manager to join a project with a Global Pharmaceutical Company based in Zurich on a contract basis for 9 months.

Key tasks and responsibilities

  • Provides project management of the activities of contract employees (external Medical Writers), including review and alignment of contributions, and ensures resolution of issues.
  • Provides financial and contractual oversight of our key MW vendors, including budget management and invoicing. Ensuresthat services are provided as per contract & within budget.
  • Manages and supports medical writing activities and processes (including document preparation and/or production) for assigned regulatory submissions or projects.
  • Coordinates preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within the assigned submission or project and adherence to Company requirements and processes.
  • Takes Project Management role on functional teams that address requirements or issues related to document preparation and production. Plans and coordinates QC activities of all documents within Medical Writings responsibilities.
  • Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
  • Fulfills documentation, document management, document administration and administrative tasks such as meeting planning, travel management etc. as required by assigned team.

Candidate’s Requirements:• Bachelor’s degree in science, health profession, or journalism.

  • 5 years’ experience writing for pharmaceutical or biotechnology, including electronic documents and submissions.
  • Project management skills
  • Understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
  • Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).

Apply: For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email Please could you send any correspondence in English. Please quote job reference 54633 in all correspondence.

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