Associate Director, Global Labeling Lead

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  Understand scientific concepts to critically assess clinical data, enable proactive interactions with appropriate stakeholders, influence the clinical development plan Develop and implement strategy for global, EU and US labeling content Identify underlying processes and principles for developing product claims representing the risks and opportunities to the project team Partner with key stakeholders to ensure product labeling is the most current, accurate, relevant and competitive to inform prescribers and patients   Who You   Are   You will have a passion for strategic regulatory labeling and will be enthusiastic to aid in the evolution of a new labeling department in a growing company. You will have   a strong scientific grounding,   an excellent eye for   detail   and a demonstrated understanding of the importance of labeling governance and compliance.     Required Skills    Bachelor's degree in a scientific or medically related discipline  6+   years pharmaceutical/ biotechnology industry regulatory experience, including   global, EU an d   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       Job Level: Management Additional Information The base compensation range for this role is: $160,000.00-$220,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.  In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being ; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement  Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance  80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit  401(k) program participation with company matched contributions Employee stock purchase plan  Tuition reimbursement of up to $10,000 per calendar year  Employee Resource Groups participation 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.