Senior Manager, Global Labeling
Biogen
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $132,000 - $176,000 per year
Job Level
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory labelinglabeling complianceSOPsEDMSregulatory tracking systemsEU Product Information (EUPI)US Prescribing Information (USPI)Company Core Data Sheet (CDS)regulatory guidelinespipeline product labeling
Soft skills
organizational skillsprioritization skillscross-functional collaborationcross-cultural collaborationwritten communicationoral communication
Certifications
Bachelor's degree in a scientific disciplineBachelor's degree in a medically related discipline