- dsm-firmenich (Princeton, NJ)
- ** Lead Expert Regulatory Affairs Pet Food** **Location: Plainsboro, NJ** **Hybrid** Are you a junior Regulatory Affairs professional ready to ... in this niche space where you can learn and grow. We are hiring a Lead Expert Regulatory Affairs Pet Food to support our Taste Texture and Health (TTH)… more
- Merck (North Wales, PA)
- **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... Global Process Lead actively engages with leadership across the Global Regulatory Affairs and Clinical Safety organization and collaborates with internal and… more
- Sumitomo Pharma (Trenton, NJ)
- …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...I-IV Research & Development Activities + As a Regional Regulatory Lead , manage regional (United States and/or… more
- Novo Nordisk (Plainsboro, NJ)
- …difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to ... The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global...Registrations Labeling Tools: + Serve as a subject matter expert in all labeling tools (SPL, TVT, Veeva Vault,… more
- Sumitomo Pharma (Trenton, NJ)
- …of scientific and medical information for key stakeholders. The Vice President will lead the global medical affairs functions for investigational and marketed ... medical affairs activities for investigational and marketed products. + Lead development of systems and processes to ensure harmonized and integrated medical… more
- Sumitomo Pharma (Trenton, NJ)
- …and responses to unsolicited requests for medical/scientific information. + Serves as Medical Affairs Lead on select therapeutics topics, and provides input into ... management peri-, pre-, and post-launch activities related to Medical Affairs function. This individual will lead program...Product Development Monthly Meetings. + Serve as Subject Matter Expert within Medical Affairs Team provide medical… more
- Sumitomo Pharma (Trenton, NJ)
- …Director, Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director, Medical Affairs Strategy. The job ... external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains professional relationships with key physicians and other… more
- Sumitomo Pharma (Trenton, NJ)
- …and experienced individual for the position of **Senior Manager, Medical Affairs Technology and Digital Innovation** . **Job Duties and Responsibilities** + ... Supports the development, implementation, execution, and oversight of Medical Information/Medical Affairs digital services and innovative digital projects as well as… more
- Novo Nordisk (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal...cycle activities + Health Systems strategy: Collaborates with medical affairs and market access teams to inform a health… more
- Novo Nordisk (Plainsboro, NJ)
- …Access and Public Affairs (MAPA), Portfolio Strategy, Commercial Excellence, Regulatory Affairs , and other relevant NNI departments to ensure alignment ... our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic...outcomes + Product Evolution + Oversee product strategy and regulatory activities related to new clinical data or label… more
- Merck (North Wales, PA)
- …on labeling to teams. + As the regulatory labeling liaison on global Regulatory Affairs subteams, your input will be essential to our operations. + You ... of labeling experience or relevant pharmaceutical industry experience (eg, Medical Affairs , Regulatory Affairs , Clinical, Pharmacovigilance). Current… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... in the US** The Director, Translational Medicine and Early Development (TMED) Lead will be responsible for contributing and/or devising the early clinical… more
- Novo Nordisk (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... to experiment with us? The Position The Integrated TA Lead is instrumental in shaping and executing NNI's strategic...to leadership + Product Evolution: Oversee product strategy and regulatory activities related to new clinical data or label… more
- Ascendis Pharma (Princeton, NJ)
- …medical information system development. + Serve as a clinical and scientific expert for Medical Affairs projects within the designated TransCon Program(s). ... is a major advantage. The candidate is expected to lead key strategic, cross-as well functional projects as part...both internal and external audiences within legal, compliance and regulatory guidelines. + Represent Ascendis Medical Affairs … more
- Taiho Oncology (Princeton, NJ)
- …and oncology, the Director, External Research will enjoy collaborating with Medical Affairs Product Leads on development of the areas of interest, execution of ... monitoring and reporting of key milestones. In addition to interactions with Medical Affairs Product Leads, this role will engage with Medical Field team, global… more
- Edwards Lifesciences (Trenton, NJ)
- …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 ... partnership with external stakeholders like KOLs,/HCPs, academic medical institutions, and regulatory authorities, you will support driving the evidence needed to… more
- Kelly Services (Horsham, PA)
- …event data collection across trials; and where appropriate, incorporation into obligatory regulatory documents Clinical Project Scientist Lead for TA IIS program ... **Job Summary:** This individual contributor will be a part of the US Medical Affairs Immunology Clinical Operations & Program Management Team and support one to two… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …standards and guidelines. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team to ensure that ... escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation...the Labeling cross functional teams including clinical, safety, medical affairs , device regulatory and commercial, to ensure… more
- University of Pennsylvania (Philadelphia, PA)
- …disease/discipline specific cancer programs within the ACC. Contingent upon funding. The CRU Regulatory Affairs Office seeks a full-time Regulatory ... Assurance Specialist (Abramson Cancer Center) Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary The Abramson Cancer Center (ACC)… more
- Novo Nordisk (Plainsboro, NJ)
- …the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... + Support the ALD clinical development program as medical lead and expert drug developer, providing input...Non-Clinical Research, Medical Writing, Program Management, Product Supply and Regulatory Affairs teams to deliver and drive… more