SpringWorks Therapeutics
Healthcare
Director,GlobalLabeling
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“Director, Global Labeling at SpringWorks Therapeutics. Skills: Global Labeling, Regulatory Affairs, Labeling Strategy. Lead development, review, approval, implementation of CCDSs, USPIs,. Prepare for senior management review and approval”
Industry & Context.
What They're Looking For.
Must Have
Bachelor's degree in science or health-related discipline, 8+ years pharmaceutical industry experience, 5+ years Regulatory Affairs Labeling experience, Deep knowledge of US/EU labeling requirements
Nice to Have
Advanced degree (PhD, MD, MS, PharmD, MBA), Advanced proficiency with MS Office, Proficiency with SharePoint, Proficiency with regulatory systems, Knowledge of global labeling requirements, Knowledge of global drug-development regulations, Knowledge of global life-cycle management regulations
What You'll Do.
implementation of CCDSs
Prepare for senior management review and approval
Ensure labeling is scientifically accurate
Ensure labeling meets healthcare professional needs
Ensure labeling meets patient needs
Provide tactical guidance on labeling process
Provide tactical guidance on regulatory requirements
Disseminate labeling for implementation
Support country regulatory affairs with local implementation
Provide input into investigational brochures
Provide input into development safety update reports
Provide input into integrated evidence planning
Develop regulatory labeling strategy for products
Develop regulatory labeling content for products
Maintain expertise regarding labeling requirements worldwide
Stay updated with FDAA labeling guidelines
Stay updated with FDAA labeling regulations
Participate in labeling negotiations with agencies
Develop labeling policies
Review labeling policies
Develop labeling standards
Review labeling standards
Provide guidance on process improvement
Drive process improvement initiatives
Support CAPA resolutions
Represent labeling on cross-functional programs
Represent labeling on advisory boards
How You'll Work.
Team & Collaboration
Cross-functional teams; Labeling teams; TA leadership; Cross-functional leadership programs; Advisory boards
Communication Scope
Written communication; Oral communication
Process & Methodology
Labeling Project Leads
Full Job Description
About SpringWorks Therapeutics: SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with rare tumors. We developed and are commercializing the first and only FDA and EC approved medicine for adults with desmoid tumors and the first and only FDA and EC approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN). At SpringWorks, we are committed to finding answers people with rare tumors need. We thrive in an atmosphere of passion and tenacity, fueled by the excitement of the possibilities science may unlock and driven to work with urgency because of the importance of our work. We value authenticity because diverse backgrounds, cultures, styles and abilities can only help us find the answers that people with rare tumors are looking for. Your Role: The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company core data sheets (CCDS), regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]) and target product labels, in line with target product profiles and overall program goals. In some instances, the Director of GL may also take on the role of Team Lead for a therapeutic area (TA), overseeing Labeling Project Leads (LPLs) working on products within that TA and fostering strong collaborations with TA leadership. Additionally, the Director of GL assists the Head of Labeling and Advertising and Promotion in preparing for and facilitating interactions with the Labeling Decision Board (LDB), and also driving forward global labeling initiatives. Location Classification – Hybrid: This role will be required to work onsite 3 days a week (Tuesday - Thursday) or more depending on business needs. #LI-Hybrid Key Accounta
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