Global Lead, Risk Minimization Programs

il y a 1 mois

Anderlecht, Belgique UCB Temps plein

**Make your mark for patients**

At UCB, nothing matters more to us than the safety and wellbeing of our patients. We make every effort to strive for quality and excellence to meet the needs of our customers and ensure the safety and efficacy of our products.

To support our commitment, we are looking for a **Global Lead, Risk Minimization Programs, being based in our Headquarters in Brussels, BE, or other relevant EU hub **to be responsible for leading the end-to-end development, implementation and oversight of Educational Programs (EP) and Controlled Access Programs (CAP) associated to Marketing Authorizations of UCB products. These programs are Risk Minimization Measures detailed in product-specific Risk Management Plans and aim to prevent or minimize the risks associated with the use of a medicinal product.

**About the role**

You will be responsible for developing, implementing and ensuring oversight on Educational Programs and Controlled access programs as regulatory commitments associated to Marketing Authorizations of UCB products in all impacted territories.

You will
- Drive the development of UCB capabilities to address EP and CAP requirements and their operational implementation
- establish effective ways of working and communication channels between global, regional and local stakeholders
- provide oversight on implementation of the EP and CAP
- identify and lead the resolution of risks/challenges associated to the activity
- act as the chair of the Core Implementation teams (product-specific)

**Who you’ll work with**

As part of the Global Medical Community, you will be working with global cross-functional core teams - including Benefit/Risk Safety Lead, Medical Affairs Lead, Supply Lead, Regulatory Lead, representatives from Quality Assurance, Legal, Business Integrity & Compliance, Market Access, and Commercial. In addition, you will interface with local implementation leaders (UCB affiliates and commercial partners as applicable).

**What you’ll do**
- Develop and maintain the Educational Programs (EP) and Controlled Access Programs (CAP) in line with RMP requirements, and their operational implementation plan, including the relevant global capabilities (systems, vendors, stakeholders)
- Establish effective ways of working and communication channels between global, regional and local stakeholders for the implementation of the programs
- Create oversight mechanisms (including production of metrics and analytics), identifying and leading resolutions of risk/challenges associated to the activity, acting as Chair of the Core Implementation teams
- Manage the budget and the vendor(s) associated to the activities
- Act as Process Data Owner for the associated computerized system(s), being responsible for its associated quality management system: development and maintenance of the associated business processes (including related controlled documentation), associated trainings and learning strategies, driving continuous improvement of the related process, system and ways of working.

**Interested? For this role we’re looking for the following education, experience and skills**
- Master’s degree (in the biomedical sciences or equivalent with experience)
- 7+ years of experience within the Pharma/Biotech industry or associated services
- Expertise in Good Pharmacovigilance Practice (GPvP) requirements and their implementation, including associated quality system management (min. 3+ experience/expertise in GxP/Pharma business process/system management (e.g. controlled document management, trainings, IT validation and associated documentations )
- Business acumen: understanding of launch activities, related components and stakeholders.
- Excellence in complex project management in matrixial environment
- Display leadership, curiosity, autonomy & accountability to drive a successful, efficient and effective outcome for the delivery of the implementation as part of successful launches
- Excellent communicator, demonstrating ability to develop trustful relationships with external and internal stakeholders, and leading cross-functional teams to accelerate delivery of qualitative and optimized outcome.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

**Why work with us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working fo

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