Compliance Partnerships Leader

Vor 2 Tagen

Basel, Schweiz Global Kader Personal Vollzeit

**INTRODUCTION**:
As a preferred supplier for Roche Basel, we are looking for an individual as

**Compliance Partnerships Leader**:

- (contract for 1 year, with possible extension). The earliest start date is within 2 months. On-site work required but home office upon agreement.

**ASSIGNMENT DESCRIPTION**:

- Lead and support the design and implementation of holistic, company-wide standards and solutions to establish the framework and the execution of Market Research And Patient Support Programs (MAPs) and Evidence Generation in accordance with Scientific Credibility standards (including Real World Evidence Scientific Projects), collaborate with the relevant stakeholders at all levels.
- Oversee and embed compliance excellence within PDMA, including safety, quality, process efficiency improvement and risk management initiatives in accordance with Roche SOPs, policies, regulatory requirements and guidelines.
- Effectively represent PDMA with internal and external stakeholders in cross-functional working groups (including committees, cross-functional initiatives, etc,..) to ensure that the needs of PDMA are considered and aligned with those of other functions.
- Communicate, provide leadership and guidance to Affiliates, Global Functions and other key stakeholders addressing PDMA related process requirements and regulations.
- Act as Subject Matter Expert (SME) during Inspections and Audits, ensure Inspection Readiness and support (or own) the preparation of responses to findings and the development and implementation of Corrective Actions and Preventive Actions (CAPA).
- As Functional training and process responsible in PDMA, ensure that the right PDMA audience is assigned to relevant trainings and foster an overall culture of adherence to quality and business requirements.

**REQUIRED PROFILE**:

- Life sciences degree or nursing equivalent or substantial experience in a clinical research/healthcare/pharma environment
- Ideally 7 to 10 years experience in the pharmaceutical or health sector (clinical trials, quality, safety)
- Experience in quality management with digital activities
- Extensive experience in GCP, GVP and healthcare compliance
- Fluency in written and spoken English
- Have appropriate knowledge of agile methodologies e.g. Scrum, Design Thinking, Lean etc.
- Demonstrates basic knowledge in digital technologies
- Have an overall understanding of the activities conducted in Medical Affairs
- Embed the Pharma Operating Principles in the way of working, including customer-centric mindset.
- Strong leadership, influencing, motivational and interpersonal skills
- Demonstrated consistent achievement of team delivery as per commitments and outcomes

**Application process**:
Interested? You can find more information here:

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