- 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
- West Pharmaceutical Services (Exton, PA)
- …a healthier environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist , Regulatory Project Management (RPM) role is ... Sr. Specialist , Regulatory Project Mgmt Requisition ID: 66496 Date: Sep 12, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs… 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)… more
- Vanguard (Wayne, PA)
- The Senior Fund Reporting Specialist reviews the most complex fund financial reporting deliverables completed by third party service providers to verify accuracy ... implementation, and administration of various strategic initiatives within the department. The Senior Fund Reporting Specialist : + Performs analytical review of… more
- Merck (West Point, PA)
- **Job Description** A new opportunity has arisen for a Senior Specialist to join the Large Molecule Technical Operation Site Support team (LMTO SS). Our team is ... issues + Support of inspections at manufacturing nodes + Authoring, reviewing regulatory documents and supporting regulatory responses + Authoring, reviewing and… more
- TD Bank (Philadelphia, PA)
- …knowledge at the enterprise, business, regulatory and industry levels + Senior specialist providing advisory services to executives, business segment leaders ... for this role. **Line of Business:** Product Management **Job Description:** The Senior Product Manager oversees the end to end management of assigned products,… more
- CSL Behring (King Of Prussia, PA)
- **R-242395 Senior R&D QA Associate, Learning Specialist ** **The Opportunity** You will be a member of the Global R&D QA department assisting the R&D QA Quality ... Management System (LMS) activities to support the R&D Quality Management System. The Senior R&D QA Associate will manage the content and maintenance of the LMS… more
- PNC (Philadelphia, PA)
- …the company's success. We are looking to hire a Compliance Program Specialist Senior within PNC's Independent Risk Management's Compliance organization ... and mitigate the identified risks. If necessary, escalates identified risks to senior team members. Identifies compliance impact on matters such as marketing… more
- PNC (Philadelphia, PA)
- …to contribute to the company's success. As a Line of Business Risk Specialist Senior within PNC's Finance Governance Oversight organization, you will be ... remotely, at manager's discretion. *Develop and oversee the FGO Financial and Regulatory framework programs *Set Financial and Regulatory Framework Methodologies… more
- American Water (Camden, NJ)
- …Facebook, Twitter and Instagram. * American Water has a Full-Time opening for a Senior Accounts Payable Specialist . If you have a passion for Analyzing all ... TODAY for Immediate Consideration!* _ *Primary Role*_ The Sr. Accounts Payable Specialist will apply understanding and knowledge of PTP's transactions, systems, and… more
- University of Pennsylvania (Philadelphia, PA)
- …and resources, and much more. Posted Job Title Clinical Research Monitoring Specialist Senior (Cancer Center) Job Profile Title Clinical Research Monitoring ... Specialist Senior Job Description Summary The Abramson...IND/IDE in both adult and pediatric research. Must understand regulatory affairs and their applications to Quality Control and… more
- Merck (West Point, PA)
- …colleagues while developing and expanding your career. **Position Overview** The Senior Specialist (Biologics External Manufacturing Operations) will be ... + Knowledge/understanding of supply chain logistics + Familiarity with regulatory filing activities/requirements + Lean/Six sigma methodology + Experience… more
- Vanguard (Malvern, PA)
- …a part of our Service Reimagined team as a Business Program Manager, Sr. Specialist ! Service Reimagined is a multi-year program that will take our operations to the ... trusted advisor throughout the project lifecycle. Monitor financial, legal, and other regulatory environments to ensure projects are aligned with the overall company… more
- Vanguard (Malvern, PA)
- …file and transitions to our Vanguard Brokerage platform. This role will serve as the senior program manager for the TSO program to deliver on the vision to drive ... information clearly and tailor style to various collaborators: team members, senior managers, clients, and key business partners.* Experience thinking strategically,… more
- Cardinal Health (Sharon Hill, PA)
- …procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant ... Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation… more
- WuXi AppTec (Philadelphia, PA)
- …Plans. + Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, GAMP, ISO, etc.). + ... initiatives, and project teams. + Participate as needed to support Client and Regulatory audits. + Works on routine assignments per written procedures, where ability… more
- Organon & Co. (Plymouth Meeting, PA)
- …are stored and distributed in accordance with all applicable Organon and regulatory requirements to meet both internal and external customer demands, the Product ... License, GDPs and contractual obligations. Ensure the quality performance of external partner (Distribution Center) through direct oversight, support and technical advice, counselling to the partners' site leadership and providing supervision as appropriate.… more
- Merck (North Wales, PA)
- …Review Team (PRT) approvals, and production. + Maintains working knowledge of regulatory guidance & delivers compliant programs. + Manages creation and monitoring of ... Agency scope of work (SOWs) and Agency evaluation process. Accountable for the operational proficiency of Agencies and other channel outsourced vendors. + Oversees the appropriate administration of promotional budgets for projects and deliverables. **Customer… more
- Merck (West Point, PA)
- …manufacturing environment. + Experience authoring technical documentation to support regulatory submissions. + Outstanding communication and people skills. + Ability ... to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development. **Preferred Experience and Skills:** + Strong scientific understanding of fermentation processes and experience with aseptic production of… more
- Merck (West Point, PA)
- …new processes and technologies. + Broad knowledge of Clinical Development and Regulatory Affairs requirements. + The ability to multi-task, work independently, and ... communicate effectively. + Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11. **\#EligibleforERP** **\#ONEGDMS** **NOTICE FOR INTERNAL APPLICANTS** In accordance… more