Associate Director, Global Labeling Lead
Biogen
8 days ago
Remote friendly (Cambridge, MA)
United States
Corporate Functions
As a Global Labeling Associate Director, you will develop the labeling strategy, lead the development and update of core, EU and US labeling documents, and oversee regional/local implementation. You may also oversee labeling strategy for other products within your Therapeutic Area.
What You’ll Do
- Lead timely creation or management of regulatory compliant, competitive, up-to-date core, EU, and US labeling documents throughout the product lifecycle (Target Label Profile, Core Data Sheet, EU SmPC, USPI)
- Lead the cross-functional Product Labeling Team to reach consensus, capture/communicate decisions, and obtain senior management endorsement
- Critically assess data and propose the labeling strategy for core, EU, and US documents, aligned with global/regional/local regulatory strategies
- Oversee distribution and tracking of Core Data Sheet updates, ensuring compliance within the Electronic Document Management System and Regulatory Tracking System
- Understand scientific concepts to assess clinical data, enable proactive stakeholder interactions, and influence the clinical development plan
- Develop and implement strategy for global, EU, and US labeling content
- Identify processes/principles for developing product claims reflecting risks and opportunities
- Partner with key stakeholders to ensure labeling is current, accurate, relevant, and competitive for prescribers and patients
Required Skills/Qualifications
- Bachelor’s degree in a scientific or medically related discipline
- 6+ years pharmaceutical/biotechnology regulatory experience, including global/EU/US labeling
- Advanced knowledge of applicable regulations, pharmacology, medicine, pharmacovigilance, and drug development
- Experience interpreting global/EU/US regulations, guidelines, and policy statements
- Proven ability to understand regulatory implications of product strategy and manage associated impacts
- Effective cross-functional and cross-cultural skills
- Highly effective written and oral communication; well organized and detail oriented
Benefits (if applicable)
- Medical, Dental, Vision, and Life insurances; Fitness/Wellness (including fitness reimbursement); Short- and Long-Term Disability
- Paid vacation (minimum 15 days) plus end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal days; sick time
- Paid Maternity and Parental Leave; 401(k) with company match; Employee stock purchase plan
- Tuition reimbursement up to $10,000/year; Employee Resource Groups participation
What You’ll Do
- Lead timely creation or management of regulatory compliant, competitive, up-to-date core, EU, and US labeling documents throughout the product lifecycle (Target Label Profile, Core Data Sheet, EU SmPC, USPI)
- Lead the cross-functional Product Labeling Team to reach consensus, capture/communicate decisions, and obtain senior management endorsement
- Critically assess data and propose the labeling strategy for core, EU, and US documents, aligned with global/regional/local regulatory strategies
- Oversee distribution and tracking of Core Data Sheet updates, ensuring compliance within the Electronic Document Management System and Regulatory Tracking System
- Understand scientific concepts to assess clinical data, enable proactive stakeholder interactions, and influence the clinical development plan
- Develop and implement strategy for global, EU, and US labeling content
- Identify processes/principles for developing product claims reflecting risks and opportunities
- Partner with key stakeholders to ensure labeling is current, accurate, relevant, and competitive for prescribers and patients
Required Skills/Qualifications
- Bachelor’s degree in a scientific or medically related discipline
- 6+ years pharmaceutical/biotechnology regulatory experience, including global/EU/US labeling
- Advanced knowledge of applicable regulations, pharmacology, medicine, pharmacovigilance, and drug development
- Experience interpreting global/EU/US regulations, guidelines, and policy statements
- Proven ability to understand regulatory implications of product strategy and manage associated impacts
- Effective cross-functional and cross-cultural skills
- Highly effective written and oral communication; well organized and detail oriented
Benefits (if applicable)
- Medical, Dental, Vision, and Life insurances; Fitness/Wellness (including fitness reimbursement); Short- and Long-Term Disability
- Paid vacation (minimum 15 days) plus end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal days; sick time
- Paid Maternity and Parental Leave; 401(k) with company match; Employee stock purchase plan
- Tuition reimbursement up to $10,000/year; Employee Resource Groups participation