Biogen
Job Scope: What is this job’s focus?
The Associate Director, EU CTR Strategy & Operations Excellence supports the Head of EU CTR in providing leadership and strategic oversight for the implementation, optimization, and continuous improvement of all EU Clinical Trials Regulation (EU CTR) processes within the organization. This role ensures consistent process execution, compliance, and operational excellence across CTIS (Clinical Trials Information System) submissions and lifecycle management activities. Acting as the process owner and operations excellence lead, the role focuses on developing and maintaining frameworks, training programs, and controls that enable a harmonized and compliant EU CTR fit for purpose operating model across all member states.
Key Responsibilities:
Strategic Process Governance and Oversight
Operational Process Control
Learning and Capability Building
Leadership and Cross-functional Collaboration
Essential Skills and Qualifications Required
Job Level: Management
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.