- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... up to 10% of the time. **Essential Functions** **:** + Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- University of Pennsylvania (Philadelphia, PA)
- …to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory ... that offer cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs … more
- IQVIA (Wayne, PA)
- ** Manager , Medical Affairs Strategy** **Overview** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services ... practice Principals and other IQVIA teams to strengthen the Manager 's Medical Affairs and consulting expertise. +...life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would… more
- Veterans Affairs, Veterans Health Administration (Wilmington, DE)
- …or deficiencies. - Complies with applicable standards, policies, procedures, and regulatory requirements. - Provides guidance and mentorship to expand professional ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Complete all application requirements detailed in… more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- Summary The Dietitian Food Service Systems Manager oversees a food service and production operation providing administrative and technical supervision over staff. ... nursing, and other services, as applicable. Monitors compliance with regulatory standards, policies, and procedures. Participates in performance improvement efforts… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus. +… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- The Senior Manager , External Engagement Strategic Planning will play a critical role in shaping and executing strategic initiatives that enhance the impact of ... Medical Affairs external stakeholder engagement activities (including those of the...Compliance and Legal to ensure all engagement strategies meet regulatory and ethical standards. **Cross-Functional Collaboration** + Work close… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …product strategy and scientific messaging. + Collaborate cross-functionally with Medical Affairs , Regulatory , Legal, and Commercial teams to ensure consistency ... The Manager , Medical Core Content is a team-level operational...Act as key support resource for the Field Medical Affairs team, managing the content repository and version control… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- The Manager , Evidence Generation, IME & Sponsorship Payments is responsible for supporting the strategic planning, execution, and operational oversight of evidence ... education (IME) grants, and external sponsorship payments within the Medical Affairs organization. This role ensures all activities are aligned with corporate… more
- University of Pennsylvania (Philadelphia, PA)
- …review proposals for compliance with sponsor and University policies and ensure Regulatory Affairs requirements are satisfied and that Conflict of Interest ... and resources, and much more. Posted Job Title Grants Manager A/B Job Profile Title Grants Manager ...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- Comcast (Philadelphia, PA)
- …Comcast. **Job Summary** Responsible for managing the daily activities of the Government Regulatory Affairs department at the state, region, or division level. ... Assists with local regulatory , franchising and public policy matters for assigned geographic...with complimentary services. Oversees additional duties related to community affairs . Consistent exercise of independent judgment and discretion in… more
- University of Pennsylvania (Philadelphia, PA)
- …to ensure data is accurate, logical, and consistent with institutional and regulatory reporting requirements. The PDE Manager , with minimal direction, is ... and resources, and much more. Posted Job Title Process Development & Efficacy (PDE) Manager Job Profile Title Technical Operations Manager - Clinical Cell and… more
- Hologic (Newark, DE)
- …the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs , Program Management, Legal, Marketing, and Operations to ... United States Marlborough, MA, United States Join the Breast and Skeletal Health Clinical Affairs team as a **Clinical Project Manager ,** leading major US and… more
- Sumitomo Pharma (Dover, DE)
- …us on LinkedIn. We are seeking a highly skilled and collaborative **Senior Manager , Web Development** to lead the design, development, and support of our company's ... This includes websites supporting Marketing, Corporate Communications, and Medical Affairs . The ideal candidate combines front-end development expertise with… more
- Penn Medicine (Philadelphia, PA)
- … Regulatory Compliance: + Works with the Division's Quality Assurance manager in functioning as liaison to accrediting/ regulatory agencies in preparation ... your life's work? Summary: + Seeking an experienced and detail-oriented manager to lead our large-scale, full-service Clinical Microbiology Laboratory. The candidate… more
- University of Pennsylvania (Philadelphia, PA)
- …and resources, and much more. Posted Job Title Cardiac Surgery Program Manager (Department of Surgery) Job Profile Title Clinical Research Program Manager ... C Job Description Summary The Cardiac Surgery Program Manager will manage clinical research coordinators and associated research staff within Department of Surgery… more
- NorthPoint Development (Philadelphia, PA)
- …of on-site and off-site utility infrastructure. This includes navigating complex energy regulatory affairs , such as large load tariffs and interconnection ... Development Manager **Department:** Development - Data Centers **Location:** Philadelphia,...closely with internal teams and external consultants to overcome regulatory and technical challenges. _-We truly believe, and I-m… more
- Eliassen Group (Dover, DE)
- …risk management, and communication across all stakeholders. * Coordinate with Regulatory Affairs to ensure documentation and submission readiness for ... **Project Manager , Med Device, R&D PMO, Design Changes** **Anywhere**...* Partner with cross-functional teams across R&D, Operations, and Regulatory to deliver product design changes that achieve measurable… more