- Oracle (Raleigh, NC)
- …is building the next generation of intelligent, cloud-based healthcare platforms - combining clinical , payer, and regulatory data at scale to transform how care ... are seeking a Senior Principal Product Manager who deeply understands the regulatory , clinical , and financial dynamics of the healthcare ecosystem - including US… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …target product profile (TPP) development, due diligence projects, and clinical - regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities ... clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study protocols,… more
- Highmark Health (Pittsburgh, PA)
- …: GENERAL OVERVIEW Assures that all department activities are compliant with regulatory guidelines/agencies, including but not limited to: NCQA, CMS, DPW, and DOH. ... with Case Management processes. Provides consultation to the department. Monitors regulatory changes, industry trends, and contract changes on an ongoing basis.… more
- Insmed Incorporated (NJ)
- …maintenance, to ensure robust supply tracking and randomization supportCollaborate with CMC, Clinical Ops, Quality, Regulatory , and Commercial Supply teams to ... a high performing team across all levelsExperience in multi-functional areas ( Clinical , Regulatory , Quality) demonstrating a broad understanding of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory ... user needs into technical requirements Coordinate risk mitigation activities across clinical , regulatory , quality, and engineering functions Perform safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other ... around rare diseases and immune disorders. Summary: The Senior Director, Clinical Safety, will lead the development and implementation of integrated project/product… more
- Formation Bio (New York, NY)
- …for programs and clinical studies. Collaborate with cross-functional teams ( Clinical Development, Regulatory , Program Management, etc.) to shape and refine ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Globus Medical, Inc. (Audubon, PA)
- …and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves ... of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …notifications. Ensure regulatory intelligence specialists have continued access to regulatory , clinical trial, and public domain information resources to ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...taxonomy terms relevant to Otsuka approved and investigational products, clinical , and business development programs. Build professional network with… more
- Medtronic (Minneapolis, MN)
- …To Have 5-8 years of industry experience, with at least 2-3 years in regulatory , clinical , or quality roles. Advanced degree in a scientific discipline ... a more connected, compassionate world. A Day in the Life SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading clinicians, researchers, and scientists… more
- Insmed Incorporated (NJ)
- …clinical studies, reviewing & interpreting clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of ... clinical development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical… more
- Saint Luke's (Kansas City, MO)
- Job Description? Responsible for all research administration activities of assigned clinical trials for Regulatory Support of Central Office of Research ... Administration. Works on all regulatory aspects of research to ensure regulations are being...and CORA files. Participate in special projects events promoting clinical trials to SLH. This is a Hybrid position… more
- Dana-Farber Cancer Institute (Boston, MA)
- …(RC) works under the direction of the Breast Oncology Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager and / or directly ... for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions,… more
- Edwards Lifesciences (Minneapolis, MN)
- … clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements Develop and deliver technical training ... your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how… more
- Bristol Myers Squibb (Cambridge, MA)
- …a matrixed industrial environment. Seeking candidates with Biomarker Lead late stage clinical trials for Phases II/III preferred. Regulatory submissions drug ... working with disease and lab scientists, as well as BMS members from clinical , medical, commercial, regulatory , and diagnostics. Individual will also engage with… more
- Merck & Co. (North Wales, PA)
- …related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory , Statistical Programming, Data Management, and other ... relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.- -Participates with management… more
- ICON Clinical Research (Raleigh, NC)
- …and we welcome you to join us on our mission to shape the future of clinical development. Sr Manager, Regulatory Affairs - IVD Location: US Remote, Portland, OR ... experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical … more
- Insmed Incorporated (San Diego, CA)
- …functional teams. You will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and ... in. Are you?About the Role:We're looking for a Director, Clinical Scientist for the Gene Therapy Clinical ...of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR,… more
- Danaher Corporation (Chaska, MN)
- …complexity, collaborating with cross-functional teams of R&D, global/regional marketing, regulatory , clinical , quality and operations. Develop and negotiating, ... the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to...Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and… more
- Insmed Incorporated (NJ)
- …credentials and experience.What You'll Do: Lead development and execution of global regulatory strategies for clinical , pre- clinical , and lifecycle ... global CTA submission strategiesDirect the planning and coordination of global regulatory submissions, including clinical trial applications for multinational… more
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