Beschreibung
The Medical Writig (MW) Junior Manager is responsible for providing support to plan and rescue the MW deliverables that support business objectives for clinical development for VBU with multiple compounds through all phases of development.Accountabilities:
- Manages and coordinates regulatory submission document preparation, including coordination of assignments to and contract writers, review, and substantive editing of documents
- Coordiates preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within the assigned submission or project and adherence requirements and processes.
- Manages and coordinates internal and external contributors for assigned regulatory submissions and projects in collaboration with stakeholders
-Reviews medical writing processes, standards, and templates
- Takes Project Management role on functional teams
Education:
- Advanced degree (PhD, PharmD) in a relevant scientific / clinical / regulatory fiels preferred; Masters degree required
- 1-3 years' experience in Global Regulatory Medical Writing for pharmaceutical or biotechnology, including electronic documents and submissions
-Ability, with minimal oversight, to coordinate the development, review, and approval of all clinical regulatory document types
- Ability to analytically evaluate and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical and therapeutic teams
- Strong project management skills including understanding of clinical timelines
Start: Asap
Duration: 6 Months
Location: Zurich (onsite)
FTE: Fulltime