- Merck (Lansing, MI)
- …immunology, neurology, cardiometabolic and others as needed by the pipeline. + Work with Regulatory Affairs to ensure that regulatory documents (eg, IDEs, ... stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development,… more
- Otsuka America Pharmaceutical Inc. (Lansing, MI)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Sumitomo Pharma (Lansing, MI)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Wolters Kluwer (Lansing, MI)
- …Manager** will be calling primarily on Librarians, Information Scientists, Heads of Global Regulatory Affairs , Directors of Medical Affairs , and the C-suite. ... They will both expand the customer base and grow existing customer business through strong product knowledge, effectively understanding customer needs and adeptly positioning Ovid's content and value proposition with our customers. The Senior Account &… more
- Highmark Health (Lansing, MI)
- …position serves as a key liaison between Claims Operations, Customer Service, Regulatory Affairs , IT, Legal and other departments, proactively identifying, ... assessing, and mitigating compliance risks. The Analyst will monitor regulatory changes, interpret their impact on operational processes, and implement effective… more
- Otsuka America Pharmaceutical Inc. (Lansing, MI)
- …appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies and optimize ... process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification… more
- Stryker (Portage, MI)
- …Degree + Minimum of 6+ years of experience in Quality Assurance, R&D, Regulatory Affairs , Service, or Operations within regulated industries, including support ... and interface directly with internal and external auditors to ensure regulatory compliance. + Manage departmental budget and oversee warranty cost containment.… more
- University of Michigan (Ann Arbor, MI)
- …Maintain compliance with the State of Michigan Department of Licensing and Regulatory Affairs CT installations ionizing radiation Rules and the American ... College of Radiology CT Accreditation Program requirements. + Effectively communicate with patients to obtain important clinical information, instruct the patient, relieve anxiety, and gain agreement during procedures, etc. + Understand and apply Guest… more
- State of Michigan (Lansing, MI)
- …or design. + Yes + No 02 Are you familiar with the Department of Licensing and Regulatory Affairs plan review and/or waiver process? + Yes + No 03 How many ... projects have you had using CPM for scheduling? + 1-2 + 3-5 + 6-10 + 10+ 04 How much experience do you have with the State of Michigan's Office Construction and Tenant Fitout Design and Construction Standards? + None + 1-2 years + 3-5 years + More than 5 years… more
- University of Michigan (Ann Arbor, MI)
- …Maintain compliance with the State of Michigan Department of Licensing and Regulatory Affairs CT installations ionizing radiation Rules and the American ... College of Radiology CT Accreditation Program requirements. + Effectively communicate with patients to obtain important clinical information, instruct the patient, relieve anxiety, and gain agreement during procedures, etc. + Understand and apply Guest… more