Associate Director, Global Labeling Lead
Takeda
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $153,600 - $241,340 per year
Job Level
Senior
About the role
- Management of Labeling Cross-Functional Teams
- Independently leads Labeling cross-functional teams driving collaboration and alignment
- Authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products
- Develops and executes a labeling implementation plan
- Interpret laws, regulations, and guidance documents relevant to labeling documentation
- Manages alignment of local labeling with CCDS for assigned products
- Appropriately escalates issues to Global Labeling management
- Conducts precedent analysis and develops strategies for assigned product labels
Requirements
- BSc degree, preferred; BA accepted
- Advanced scientific degree (MSc, PhD, or PharmD) preferred
- 8+ years of pharmaceutical industry experience
- 6 years of labeling experience or combination of 5+ years regulatory and/or related experience
- Strong knowledge of US and EU product labeling requirements
- Knowledge of US and/or EU regulatory requirements and guidelines
- Ability to create and update product labeling for regulatory submissions
- Ability to develop target labeling profile (TLP) with minimal supervision
Benefits
- Medical, dental, vision insurance
- 401(k) plan and company match
- Short-term and long-term disability coverage
- Paid time off
- Company holidays
- Tuition reimbursement program
- Paid volunteer time off
- Well-being benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
labelingTLPCCDSUSPIEU SmPClabeling implementation planprecedent analysisregulatory submissionstarget labeling profile
Soft skills
collaborationalignmentissue escalation
Certifications
BSc degreeBA degreeMScPhDPharmD