- Novo Nordisk Inc. (Plainsboro, NJ)
- 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
- Merck & Co. (North Wales, PA)
- …Office (PMO), and Administrative Professionals. - Position Description/Summary - The Senior Specialist , Project Manage r is a core member of Early Drug Development ... and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive cross-functional… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Sr Specialist , Contract Analyst is responsible for contract adjudication, analysis, and customer contact and coordination activities in support of ... acumen. The highest level of compliance with contract terms and conditions, regulatory requirements, and laws is required, while also striving for strong business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile Title Clinical ... Research Regulatory Specialist B Job Description Summary The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and… more
- University of Pennsylvania (Philadelphia, PA)
- …Title Regulatory Affairs Specialist C Job Profile Title Clinical Research Regulatory Specialist C Job Description Summary The Regulatory Affairs ... C functions independently with minimal supervision on complex protocols. The Regulatory Affairs Specialist C reviews and creates core documents (protocols,… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs routine maintenance of… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Regulatory Affairs Specialist is responsible for implementing regulatory strategies ... regulations in the United States (US) and European Union (EU). The Regulatory Affairs Specialist is responsible for providing regulatory input for … more
- Prime Therapeutics (Trenton, NJ)
- …It fuels our passion and drives every decision we make. **Job Posting Title** Regulatory Audit Specialist Sr. - Remote **Job Description** The Regulatory ... Audit Specialist Sr is accountable for managing regulatory and/or client-initiated audits, by evaluating and understanding the purpose of various audit types and… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The ESG Regulatory Compliance Specialist , is responsible for the evaluation and management of ... with business leaders to identify and mitigate financial, operational, legal, regulatory , and reputational risks. The successful candidate will also be responsible… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible for ... upcoming regulations in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible for providing advanced level regulatory input… more
- Penn Medicine (Bala Cynwyd, PA)
- …our future each day. Are you living your life's work? Summary: + The Regulatory and Accreditation Specialist establishes and implements regulatory standards ... improving and maintaining regulatory clinical documentation standards. The Specialist will facilitate survey readiness and monitor for ongoing clinical… more
- Amentum (Philadelphia, PA)
- …and deconstruction. As a key member of the project team, the Site Acquisition Specialist - Regulatory will be responsible for regulatory , permitting, site ... and overall project coordination. You will be creating, and reviewing, regulatory compliance, permitting, and site acquisition documentation associated with wireless… more
- University of Pennsylvania (Philadelphia, PA)
- …programs and resources, and much more. Posted Job Title Quality Assurance Specialist ( Regulatory ) CVPF(Center for Cellular Immunotherapy) Job Profile Title ... Research Coordinator Senior Job Description Summary The Quality Assurance Specialist will work within the Clinical Cell and Vaccine Production Facility (CVPF) for… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …other than @Olympus.com, it is likely not legitimate._ **Job Description** The Senior Specialist , Regulatory Affairs Operations - Regulatory Intelligence is ... cross functional stakeholders, and facilitating the activities described by a global regulatory intelligence process. **Job Duties** The Senior Specialist , … more
- Globus Medical, Inc. (Audubon, PA)
- …possible. **Position Summary** **:** Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with ... Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps… more
- Penn Medicine (Philadelphia, PA)
- …part in and respond to any necessary follow-up of both announced and unannounced regulatory body site visits with a focus on the Clinical Practices of the University ... / regulations and assess, develop, or participate in, as appropriate, regulatory advocacy approachesCoordinate with others, as appropriate, to resolve highly complex… more
- University of Pennsylvania (Philadelphia, PA)
- …Assurance Specialist (Abramson Cancer Center) Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary The Abramson Cancer Center ... The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase… more
- University of Pennsylvania (Philadelphia, PA)
- …off site and flexible hours. Clinical Research Coordinator B will assist the regulatory specialist in preparing for all local and Central Institutional Review ... responsibilities above, the Clinical Research Coordinator B will assist the regulatory specialist in preparing for all local and Central Institutional Review… more
- University of Pennsylvania (Philadelphia, PA)
- …when applicable; Tracking AE/SAE, maintaining documentation, and study logs; Coordinating with regulatory specialist when regulatory entities report is ... the execution of the trials is adherence to the protocol and regulatory compliance; Maintaining regulatory documents per sponsor requirements, University of… more
