Medical Writer Project Manager

**My duties**
- Manages and coordinates document preparation, including coordination of assignments and contract writers, review, and substantive editing of documents
- Manages MW oversight of our key external vendors including financial oversight
- Manages and coordinates contributors for assigned regulatory submissions and projects in collaboration with stakeholders
- Participates on relevant project teams and task forces, and provides functional and cross
- functional guidance on a wide range of issues related to document preparation and production
- Requirements (style, electronic integrity, and process). Assures overall quality by planning and coordinating Quality Control of all documents under Medical Writing responsibility
- 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. Ensures that 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 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

**My qualifications**
- Advanced degree in science, health profession, or journalism
- Experience writing for pharmaceutical or biotechnology, including electronic documents and submissions
- 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)
- Ability to understand guidelines and requirements related to the preparation and production of regulatory documents and submissions
- Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas
- Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers

**My benefits**
- Reporting to the Medical Writing and Development Excellence Lead
- Supporting the Medical writing team who are responsible for all global vaccine projects
- Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards)

**About Hays**
- With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages - completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.**My contact at Hays**

**Reference number**
653135/1

**Contact**
Phone: +41 44 225 50 00