Global Labeling Strategist
3 weeks ago
At Takeda Pharmaceutical, we are transforming patient care through innovative specialty pharmaceuticals and best-in-class patient support programs.
Job OverviewThis role is a key position in the development of novel therapies and support systems for patients worldwide. As Associate Director, Global Labeling Lead, you will play a critical part in shaping the future of healthcare by leading cross-functional teams and driving labeling strategy and content.
Responsibilities- Labeling Strategy and Content: Develop and implement comprehensive labeling strategies and content for multiple assigned products, ensuring compliance with US and EU regulations and guidelines.
- Cross-Functional Team Leadership: Manage and lead Labeling Cross-Functional Teams, driving collaboration and alignment among team members to achieve common goals.
- Regulatory Compliance: Ensure that labeling content and processes conform to regulatory requirements, interpreting laws, regulations, and guidance documents relevant to drug development.
- Vendor Management: Oversee external vendors responsible for labeling activities, ensuring seamless coordination, timely delivery, and adherence to quality standards.
- Education: Bachelor's degree (BSc) or equivalent; advanced scientific degrees preferred.
- Experience: 8+ years of pharmaceutical industry experience, including 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.
- Skills: Strong knowledge of US and EU product labeling requirements, regulations, and guidelines; ability to create, revise, and update product labeling; excellent leadership and communication skills.
We offer a competitive salary range of $149,100 - $234,300 annually, commensurate with qualifications and experience. In addition to a comprehensive benefits package, which includes medical, dental, vision insurance, 401(k) plan, short-term and long-term disability coverage, basic life insurance, tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, you will also receive up to 80 hours of sick time per calendar year and 120 hours of paid vacation.
Takeda Pharmaceutical is an equal opportunities employer committed to creating a diverse workforce and providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or other protected characteristics.
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