Associate Director, Global Labeling Lead

Biogen•Cambridge, MA

20h•$160,000 - $220,000

About The Position

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.

Requirements

Bachelor's degree in a scientific or medically related discipline
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

Responsibilities

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

Benefits

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