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Senior Manager, Global Labeling
Location
United States
Posted
146 days ago
Salary
$132K - $176K / year
Seniority
Senior
Job Description
Senior Manager, Global Labeling
Biogen
• Lead creation and maintenance of core, EU, and US labeling documents for approved products • Support development of labeling for pipeline products • Drive cross-functional labeling team discussions and secure senior management endorsement • Propose and align labeling strategies with regulatory objectives • Oversee distribution and tracking of Company Core Data Sheet (CDS) updates • Deliver EU Product Information (EUPI) and US Prescribing Information (USPI) in line with regulations • Oversee coordination of artwork and EMA linguistic reviews • Ensure compliance with Health Authority timelines for SPL submissions and regional implementation • Maintain labeling compliance, SOPs, and support audits • Provide training and guidance on labeling processes and standards
Job Requirements
- Bachelor's degree in a scientific or medically related discipline
- 5+ years pharmaceutical/ biotechnology industry regulatory experience, including regulatory labeling
- Strong knowledge of global labeling regulations and processes
- Proficiency with EDMS and regulatory tracking systems
- Experience interpreting regulatory guidelines and policies
- Excellent organizational and prioritization skills
- Effective cross-functional and cross-cultural collaboration
- Strong written and oral communication skills
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
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