Documentation and Administrative Manager - Basel, Schweiz - Swedish Orphan Biovitrum
vor 3 Wochen
Beschreibung
Role & Function
The Documentation and Administrative Manager will be responsible for providing the necessary support for documentation and administrative management of activities within PDTM to support development and geographic expansion of drug products.
Key Responsibilities
- Ensure mapping and filing of PDTM documentation (internal & external from CROs or partners) according to current or newly implemented processes and systems (including TMF filing and quality check)
- Liaise with Subject Matter experts (SMEs) within PDTM to identify relevant documentation
- Liaise with external partners and PDTM SMEs for outsourced activities under PDTM mandate where required (for CRO selection, contracting, invoicing, documentation review and support for study monitoring and closing)
- Contract management in Sobi Contract Management System (CMS)
- Perform monthly followup for accruals and invoices under PDTM mandate in liaison with internal and external stakeholders
- Handling of purchase orders and invoices for the department
- Maintain personnel files and organizational documentation for the department for inspection readiness
- Organize PDTM meetings (identify relevant topics, liaise with attendees, create agenda and distribute minutes)
Qualifications
- Minimum 3 years of relevant experience as Documentation & Administrative Manager
- Good understanding of Clinical and Non-Clinical environment in Pharma is a plus
- Relevant experience in pharma/biotech industry
- Ability to work effectively and collaboratively across functions
- Strong organizational and decisionmaking skills and able to work to short deadlines
- Ability to multitask and work under pressure
- Strong working knowledge of Microsoft Office including Microsoft Word, PowerPoint, Excel, Outlook ,Teams and contract management system
- Good command of written and spoken English
Salary:
Up to CHF1.00 per year
Schedule:
- Monday to Friday
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