- Novo Nordisk Inc. (Minneapolis, MN)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Sumitomo Pharma (St. Paul, MN)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Merck (St. Paul, MN)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices and combination products, for due diligence… more
- Danaher Corporation (Minneapolis, MN)
- … Affairs department and report to the Vice President of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs ... that safeguard and improve human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and will be fully remote. At Aldevron, we… more
- Takeda Pharmaceuticals (St. Paul, MN)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- Post Holdings Inc. (Hopkins, MN)
- …walk or outdoor lunch before, within, or after your work day. Responsibilities The Director of Regulatory Affairs and Customer Compliance is responsible for ... overseeing and providing leadership for all regulatory and export compliance matters within the MFI Integrated Supply Chain. The position must effectively… more
- Sumitomo Pharma (St. Paul, MN)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key ... member of the Medical Affairs team reporting to the Executive Director ,...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Sumitomo Pharma (St. Paul, MN)
- …Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... company programs and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains professional relationships with… more
- Sumitomo Pharma (St. Paul, MN)
- …, Medical Strategy (Prostate Cancer)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... initiatives and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties and Responsibilities**… more
- Merck (St. Paul, MN)
- **Job Description** **Role Summary** + The Health Systems Medical Affairs Director (HS MAD) is a therapeutic and disease expert who develops ongoing professional ... in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also...resource for the HS MAD Team Lead, HS Executive Director Medical Affairs , and other members of… more
- Danaher Corporation (New Brighton, MN)
- …in Bronshoj (Denmark) and the US Hub in Minneapolis. This position will report to the Director of Clinical Affairs in the US and will be based in New Brighton, ... tools that address the world's biggest health challenges. The Sr. Clinical Affairs Manager is responsible for directly managing a team driving clinician studies… more
- Takeda Pharmaceuticals (St. Paul, MN)
- … Project Management and Strategic Planning - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management… more
- Takeda Pharmaceuticals (St. Paul, MN)
- …innovative opportunities to improve processes and infrastructure in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology ... goals. + Demonstrates leadership and a deep understanding of global regulatory affairs (GRA) information/data regulations and guidelines, proactively addressing… more
- United Therapeutics (St. Paul, MN)
- …primarily responsible for providing expert legal support to Marketing, Sales, Medical Affairs , Patient Relations, Regulatory Affairs and Corporate ... Company's various products. + Provide guidance to Sales, Marketing, Medical Affairs , Patient Relations, Regulatory and Corporate Compliance departments related… more
- Sumitomo Pharma (St. Paul, MN)
- …. **Job Overview** The **Executive Director Head of Medical Strategy** will ... be a key member of the Medical Affairs Leadership team reporting to the Vice President,...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Eurofins (Minneapolis, MN)
- …to the entire product lifecycle, from pre-clinical and clinical support to regulatory affairs and market access. Key Responsibilities: + Strategic Leadership ... the entire network of Eurofins companies. Position Overview: The Director of Consulting Services will lead and develop our...test result management. + Life Cycle Management and Outsourced Regulatory Affairs : Offer ongoing support in … more
- Abbott (Plymouth, MN)
- …stakeholders. + Keep commercial organization and other internal functions (eg, Clinical, Regulatory Affairs , R&D, Commercial, Medical Affairs ) informed about ... various technologies and will coordinate extensively both internally (with Marketing, Clinical Affairs , Regulatory , Medical Affairs , Sales and other… more
- Edwards Lifesciences (Minneapolis, MN)
- …for Medicare Services (CMS) and/or Medicare Administrative Contractors (MAC), Medicaid, Veteran Affairs (VA) and commercial payers. **The Director , Global Health ... working with various internal business partners (especially Sales, Marketing, Clinical, Regulatory , Legal, and Government Affairs staff) to provide insight… more
- Takeda Pharmaceuticals (St. Paul, MN)
- …Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates the process to ... plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a key role in the PDT… more
- Edwards Lifesciences (St. Paul, MN)
- …healthier lives. Join us and be part of our inspiring journey. As the ** Director , Clinical Affairs (Clinical Data & Evidence Strategy),** you will be responsible ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for developing the strategy… more