Takeda
Biotechnology • Pharmaceuticals • Healthcare Insurance
Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.
10,000+ employees
Founded 1781
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
💰 Grant on 2016-08
Associate Director, Global Labeling Lead
Job not on LinkedIn
October 28
Takeda
Biotechnology • Pharmaceuticals • Healthcare Insurance
Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.
10,000+ employees
Founded 1781
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
💰 Grant on 2016-08
📋 Description
• 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
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