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 implementationestablish effective ways of working and communication channels between global, regional and local stakeholdersprovide oversight on implementation of the EP and CAPidentify and lead the resolution of risks/challenges associated to the activityact as the chair of the Core Implementation teams (product-specific)be the UCB subject matter expert for EP and CAP.
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 programsCreate 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 teamsManage the budget and the vendor(s) associated to the activitiesAct 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. Act as UCB subject matter expert for EP and CAP, including during audits and inspections (as applicable, per scope)
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 environmentDisplay leadership, curiosity, autonomy & accountability to drive a successful, efficient and effective outcome for the delivery of the implementation as part of successful launchesQuality-oriented, eye for details, organized, structured, synthetic, pragmatic, able to apply theoretical knowledge in practical situationsExcellent 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 for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.