Company Description
Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
Job Description
About This Role
The purpose of the Global Labeling group is to drive Biogen's regulatory labeling strategy and ensure that labeling documents are of high quality and compliant for the safe and effective use of our products globally.
As a Global Labeling Associate Director, you would be responsible for developing the labeling strategy, leading the development and update of core, EU and US labeling documents and for overseeing implementation at a regional and local level. In this role, you may be responsible for overseeing the strategy for other products within your Therapeutic Area.
What You'll Do
- Lead timely creation or management of regulatory compliant, competitive and up to date core, EU and US labeling documents throughout the product lifecycle including the Target Label Profile, Core Data Sheet, EU SmPC and USPI
- Lead the cross functional product Labeling Team to reach consensus on labeling matters, accurately capture and communicate decisions, and obtain endorsement by senior management
- Critically assess the data and propose the labeling strategy to be followed in core, EU and US labeling documents, ensuring alignment with global, regional and local regulatory strategies
- Oversee distribution and tracking of Core Data Sheet updates for assigned products, ensuring compliance is maintained within the Electronic Document Management System and the Regulatory Tracking System
Who You Are
You have a passion for strategic regulatory labeling and are enthusiastic to aid in the evolution of a new labeling department in a growing company. You have a strong scientific grounding, an excellent eye for detail, and a demonstrated understanding of the importance of labeling governance and compliance.
Qualifications
Required Skills
- 6+ years pharmaceutical/ biotechnology industry regulatory experience, including global, EU and US regulatory labeling
- Advanced knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development
- Experience in interpretation of global, EU and US regulations, guidelines, policy statements, etc.
- Proven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impacts
- Demonstrate effective cross-functional and cross-cultural skills to effectively interact with global counterparts
- Well organized, detail oriented, highly effective written and oral communication skills
- Bachelor's degree in a scientific or medically related discipline
- Must be located in the Eastern or Central US Time Zones
Additional Information
The base compensation range for this role is $140,000 - $233,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
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 our DE&I efforts.
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.
