Documentation and Administration Manager

vor 1 Tag

Basel, Schweiz Sobi Vollzeit

**Documentation and Administrative Manager**

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 follow-up 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 decision-making skills and able to work to short deadlines
- Ability to multi-task 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

**Personal attributes**
- Great social skills, easily establish and develop relationships within and outside Sobi and excellent communication skills
- Structured approach to work with demonstrated ability to focus on details
- Critical thinking and problem-solving skills
- Strong autonomous and high team spirit with a can-do attitude.
- High level of confidentiality and integrity
- In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership

**Location**

The position will be based in Basel, Switzerland

**Why Join Us?**

We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

**Sobi Culture**

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.

This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain.

Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

**An Equal Opportunity Employer**

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