Medical Writing Project Manager
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 aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote job reference 54633 in all correspondence.
