- GRAIL (Madison, WI)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- GE HealthCare (Waukesha, WI)
- …market requirements. + Leads a team of regulatory professionals in execution of regulatory affairs tasks in support of the businesses. + Prepares global ... devices, pharmaceuticals, or biologics. + A minimum of 10 years' experience in Regulatory Affairs / Clinical Trials / Quality. + A minimum of 5 years' experience… more
- Sumitomo Pharma (Madison, WI)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- Otsuka America Pharmaceutical Inc. (Madison, WI)
- As a senior leader within Medical Affairs , the Executive Director will serve as a strategic thought partner and Chief of Staff to the Vice President of ... capabilities aligned with Otsuka's vision, direction, and growth strategy. The Executive Director , Medical Affairs Strategy, Excellence & Operations will lead… more
- Cengage Group (Madison, WI)
- …day. To learn more, please see https://www.cengagegroup.com/about/inclusion-and-belonging/ . The ** Senior Director of** **State** **Government Affairs ** ... Communications Officer and work in partnership with the Sr Director of Federal Government Affairs in addition...+ Use your deep knowledge of state legislative and regulatory processes to create strategies for effective engagement that… more
- Oracle (Madison, WI)
- **Job Description** Fortune 100 information technology company seeks a Director , State and Local Government Affairs , reporting to the Vice President, State ... Government Affairs . The Director , State and Local Government Affairs will...state and local officials including executive and legislative branch, regulatory officials, municipal government and other relevant stakeholders. +… more
- Otsuka America Pharmaceutical Inc. (Madison, WI)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads the...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Otsuka America Pharmaceutical Inc. (Madison, WI)
- The Senior Director , Medical Communications, CNS directs and provides strategic leadership for the global and US scientific communication strategy for the ... accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs ,… more
- Otsuka America Pharmaceutical Inc. (Madison, WI)
- **Job Summary** The Senior Director , Medical Communications, Nephrology & Immunology directs and provides strategic leadership for the global scientific ... accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy. The role is a key leadership position within the Nephrology… more
- Otsuka America Pharmaceutical Inc. (Madison, WI)
- …stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible ... **Job Description** **Position Summary** Otsuka is seeking an experienced and visionary Senior Director , Global Clinical Development (GCD), with experience in… more
- Otsuka America Pharmaceutical Inc. (Madison, WI)
- …of the time based on business needs. You will report to the Senior Director , Biostatistics. **Job Description** + Provides statistical analysis plan, including ... for the maintenance of everyday health. As an Associate Director , Biostatistician, you will be a champion of Otsuka's...sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex… more
- Otsuka America Pharmaceutical Inc. (Madison, WI)
- …alignment with corporate quality objectives + Cross-functional Leadership:Collaborate with Regulatory Affairs , Technical Operations, Manufacturing, and Supply ... **Job Summary** The Associate Director , Global Product Quality - GMP Process is...preferred). + 8+ years of experience in pharmaceutical quality, regulatory affairs , or technical operations. + Proven… more
- Cardinal Health (Madison, WI)
- …joins a team of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs . **Responsibilities:** + Collaborate across ... peers, customers, and suppliers at various management levels + Interact with senior management + Independently lead Medical Affairs projects + Utilizes… more
- Festival Foods (WI)
- …practical problems. + Complete additional duties as assigned by the Food Protection and Regulatory Affairs Director + OSHA involvement + Oversee OSHA ... our culture of safety and care across our organization. Reporting to the Senior Director of Asset Protection, you'll lead strategic initiatives that protect… more
