- West Pharmaceutical Services (Exton, PA)
- Sr . Specialist , Regulatory Project Mgmt Requisition ID: 66496 Date: Sep 12, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... healthier environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist , Regulatory Project Management (RPM) role is… 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
- TD Bank (Mount Laurel, NJ)
- …in their in a complex field and knowledge of broader related areas + Senior specialist provides advisory services to executives, business segment leaders and ... this role. **Line of Business:** Enterprise Enabling Functions **Job Description:** The Senior Change Management Specialist leads change management efforts on… more
- ThermoFisher Scientific (Wilmington, DE)
- …process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from ... monitoring environments (ie FSO, FSP, Government, etc.). Acts as a site processes specialist , ensuring that the trial is conducted in accordance with the approved… more
- Merck (West Point, PA)
- **Job Description** The Senior Specialist , Validation, will be responsible for completion of validation execution and oversight of validation contractor ... be supporting Integrated Product Teams (IPTs) involved in vaccine manufacturing. The Senior Specialist will prepare review and approve validation documentation… more
- Vanguard (Malvern, PA)
- …forces, competition, and trends to act as a trusted advisor throughout the project lifecycle. Monitors financial, legal, and other regulatory environments to ... 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… 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 ... and trend evaluations, developing and introducing process enhancements, and providing project leadership. Our goal is to continuously deliver outstanding value to… more
- Medtronic (Philadelphia, PA)
- …answer questions from regulatory agencies as needed + Create and manage project schedule for each document/ identify task to be assigned to other colleagues. ... being accountable, having a voice, and taking action. In this clinical specialist role, you will have additional responsibility providing support for CathWorks. To… 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 ... activities to support the R&D Quality Management System. The Senior R&D QA Associate will manage the content and...understanding of quality systems and appreciation of need for regulatory compliance. + Influence and ensure project … 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 ... technical and operational aspects of Vaccine and Biological products + Project management and oversight capabilities + Supply chain planning familiarity/experience,… more
- WuXi AppTec (Philadelphia, PA)
- …risk assessments, requirements traceability, URS, FDS, procedural mappings and Validation Project Plans. + Stay current with changes to GXP, including FDA ... and EU and other regulatory bodies as well as guidance documents (ie: ICH,...+ Participate in quality and process improvement initiatives, and project teams. + Participate as needed to support Client… more
- Merck (West Point, PA)
- …subject position will be responsible for the following:** + Functioning as a project lead of the technical operations lab team through executing lab-scale process ... manufacturing environment. + Experience authoring technical documentation to support regulatory submissions. + Outstanding communication and people skills. + Ability… 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 ... projects and stakeholders. + Proven problem solving and exceptional project management skills. + Strong communications skills and self-motivated. **Preferred… more
- University of Pennsylvania (Philadelphia, PA)
- …Operations, Compliance and Monitoring (DOCM) is seeking a The Clinical Research Quality Specialist , Sr . to support our clinical research mission. The ACC ... across the US and in other countries. The Quality Specialist , Sr . is responsible for scheduling, coordinating...centers. Additional experience in clinical research ie Data Management, Project Management, Drug Safety are a strong plus. The… more
- TD Bank (Mount Laurel, NJ)
- …with staff and senior management of the Bank with respect to regulatory risk matters. + Empowered to make prudent professional decisions in rendering advice and ... activities + Centralized policy and reports inventories + Internal Audit, regulatory exam, and ongoing supervision management, finding tracking, and remediation… more
- TD Bank (Mount Laurel, NJ)
- …the quality and timeliness of all change management deliverables for the program / project or multiple workstreams. + Consults with senior stakeholders to ensure ... **Line of Business:** Enterprise Enabling Functions **Job Description:** The Change Mgmt Specialist Lead plans and/or executes on the end-to-end delivery of Change… more
- University of Pennsylvania (Philadelphia, PA)
- …processes to ensure regulatory compliance and timely completion of project /program deliverables. Closely collaborates with Senior Research Specialists and ... processes to ensure regulatory compliance and timely completion of project /program deliverables. Closely collaborates with Senior Research Specialists and… more
- University of Pennsylvania (Philadelphia, PA)
- …processes to ensure regulatory compliance and timely completion of project /program deliverables. Closely collaborates with Senior Research Specialists and ... processes to ensure regulatory compliance and timely completion of project /program deliverables. Closely collaborates with Senior Research Specialists and… more
- TD Bank (Philadelphia, PA)
- …Business:** Data & Analytics **Job Description:** The Business Information Management Specialist provides business technical leadership across a broad range of ... areas of data and analytics. Works independently as a senior lead and may manage and direct activities related...matter expert in multiple areas and consults with clients/or project teams with respect to all aspects of business… more