- Humana (St. Paul, MN)
- …The person in this position will report to the Vice President of Strategy and State Affairs and be responsible for public policy development to inform thought ... caring community and help us put health first** The Director of State Public Policy role resides...Under direction of the Vice President of Strategy and State Affairs , and with input from enterprise… more
- Philips (Plymouth, MN)
- … regulatory files and tracking databases as required. + Reporting to the Director of Regulatory Affairs - Coronary Vascular you will collaborate with ... The Principal Regulatory Affairs Specialist will play a...partner status, or any other category protected by federal, state and/or local laws. As an equal opportunity employer,… more
- Philips (Plymouth, MN)
- …body audits. Implements internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will ... Recommends strategies for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems and assists… more
- Cardinal Health (St. Paul, MN)
- …capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + Nonclinical ... brand for post-approval success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory Sciences is a… more
- Takeda Pharmaceuticals (St. Paul, MN)
- …, Global Regulatory Project Management, GI 2 within our Global Regulatory Affairs organization, based remotely. **_OBJECTIVES/PURPOSE_** + Partners with the ... the pharmaceutical industry and drug development project management and regulatory affairs (eg, clinical development, the prescription...TRAVEL** + Remote within the US + Travel: The Director is expected to come to Quarterly GRA meetings… more
- Takeda Pharmaceuticals (St. Paul, MN)
- …You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be responsible...+ Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts… more
- Sumitomo Pharma (St. Paul, MN)
- …changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + Responsible for compliance with ... **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA)...ensures compliance with GMPs, SMPA procedures and applicable global Regulatory guidelines by providing oversight and management of the… more
- Merck (St. Paul, MN)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- CSL Plasma (Minneapolis, MN)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... in such capacity provides medical oversight in compliance with applicable Federal and State regulations including the applicable sections of Title 21 of the Code of… more
- Post Holdings Inc. (Hopkins, MN)
- … compliance with the FDA and USDA FSIS. The position will report to the Director of Regulatory Affairs and Customer Compliance. DUTIES AND RESPONSIBILITIES: ... food safety compliance within MFI. Provides support for plant operations regarding regulatory matters within MFI. The position will interact with other internal… more
- Sumitomo Pharma (St. Paul, MN)
- …impacting business decisions. + Proficient in GMP manufacturing, quality assurance, regulatory affairs , and clinical operations. + Demonstrated ability to ... **Executive Director , Commercial Supply Chain** Sumitomo Pharma America (SMPA)...of all products. + Identify risks (business, performance, quality, regulatory , external, etc.) to ensure supply and work with… more
- Bristol Myers Squibb (Minneapolis, MN)
- …and spirit of independence and love of challenge._ **Job Description** The Region Director (RD) is a remote leadership position that is primarily responsible for ... satisfaction and productivity. This position reports into a national Field Medical Director role. The RD position is underpinned with the expectation of leadership… more
- Enviri Corporation (Blaine, MN)
- …or the ability to rapidly establish relationships within the C-level, Regulatory Affairs , Quality, Procurement, Supply Chain, Operations and Marketing ... to rapidly establish relationships within the Environmental Health and Safety, Regulatory Affairs , Quality, Procurement, Supply Chain, Operations and Marketing… more
- Merck (St. Paul, MN)
- …Compile, review and submit PQC reports and provide PQC data /line listings to US Regulatory Affairs for inclusion in Drug Experience Reports to be submitted to ... Specialist, Quality Management Systems and Compliance reports to the Director , Animal Health Quality Management Systems and Compliance and...regulatory authorities including the US FDA. + Support global… more
- AbbVie (Minneapolis, MN)
- …patient or compassionate use basis, subject to all applicable legal and regulatory requirements. * Must provide insights on the current clinical practice, facilitate ... * Support Enterprise Critical Studies' related activities from a medical affairs perspective and contributing to meeting study timelines. * Provide scientific… more
- Prime Therapeutics (St. Paul, MN)
- …determinations with requesting physicians or ordering providers, when available, within the regulatory time frame of the request by phone or fax. + Provides ... training per inter-rater reliability process. + Assists the VP, Medical Affairs in research activities/questions related to the Utilization Management process,… more
- Medtronic (Minneapolis, MN)
- …success with managing with influence. * Extensive recruitment experience in Clinical and Regulatory Affairs , Medical Affairs and Quality * Industry ... lead and deliver a "white-glove" senior-executive recruitment experience for Senior Director and VP+ positions at Medtronic's business units and/or functional… more
- Sanofi Group (St. Paul, MN)
- …report into the US Medical Immunology team which is a segment of the Medical Affairs Specialty Care organization. Our Medical Affairs function serves as a valued ... strategic partner with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support patients' needs. The US Medical Immunology team is… more
- Sanofi Group (St. Paul, MN)
- …are always within label, and consistent with commercial, compliance, legal and regulatory guidelines. A TLL will work closely, and within approved SOPs, with ... Business Managers) in addition to home office-based colleagues in Marketing, Medical Affairs , Sales, and Market Access. The behaviors that are critical for success… more
- Universal Health Services (Eden Prairie, MN)
- …to: Nursing, Admissions, Business Development, Process Improvement, Finance, Clinical Services, Regulatory Affairs that effectively drive patient care outcomes + ... CEO at a Behavioral Health facility or as a Director of a multi-unit psych department. + A working...practices and clinical operations. + An advanced knowledge of state and federal regulatory and various accreditation… more