- Daiichi Sankyo, Inc. (Bernards, NJ)
- …handles sensitive documents that may impact multiple organizational units or project teams. This position has advanced skills in technology systems, content ... implementation of culture change initiatives, Global QA Transformation activities and project level oversight including end to end risk-based deployment in relation… more
- Merck & Co. (Rahway, NJ)
- …biologics, vaccines, antibody drug conjugates (ADCs), in addition to others.- --The Senior Specialist , Engineering will serve as a business representative in ... the FLEx Sterile Expansion Project which is currently in Conceptual Design Phase (also known as Front End Loading Phase II, FEL-2).- The FLEx Sterile Expansion … more
- Merck & Co. (North Wales, PA)
- …Review Team (PRT) approvals, and production.Maintains working knowledge of regulatory guidance & delivers compliant programs.Manages creation and monitoring of ... managing multiple projects and stakeholders.Proven problem solving and exceptional project management skills.Strong communications skills and self-motivated.- Preferred Knowledge… more
- Merck & Co. (Rahway, NJ)
- …supply to customers and patients on time, every time, across the globe. This QA Senior Specialist in Digital and Data Quality will be responsible for the ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- Merck & Co. (Rahway, NJ)
- …CDS technical initiatives. Supporting the clinical database manager/supervisor in project planning, manpower projections, and resource allocation across therapy ... maintain good working relationships across different functional areas. Solid project management skills. Excellent leadership, verbal and written communication,… more
- Merck & Co. (Philadelphia, PA)
- …leverage expertise from other internal departmentsDetail oriented and strong project /time management skillsAbility to identify and lead process improvementsStrong ... and / or improve Third Party/Supplier relationshipsKnowledge of Finance, Regulatory /Quality, Privacy and Legal expectations for Global ProcurementRole is expected… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on study and project teams.Produces independent writing for publications and regulatory documents.Serves as a specialist in PK-PD and Pop PK-PD concepts ... on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and Pop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on study and project teamsProduces independent writing for publications & regulatory documentsServes as a specialist in PK-PD and Pop PK-PD concepts, ... conduct/develop PK-PD and Pop PK-PD analyses,Participates in KOL and regulatory interactions at project level, interacts with... team members, and to a limited extent with senior management, and outside vendors; works independently for all… more
- BioAgilytix (Durham, NC)
- …laboratory, including storage units and other equipment, under supervision of senior managementExecutes Technician and Specialist responsibilities including but ... responsibilities; responsible for overseeing on-time availability of samples and regulatory (GxP, CDX-CAP/CLIA) compliant processing of samples; and scheduling the… more
- Arthrex (Naples, FL)
- …development and medical education in orthopedics. Arthrex is actively searching for a Senior Sterilization Specialist for our global headquarters in Naples, FL ... ISO 11137, ISO 17665, etc. as well as domestic and foreign regulatory requirements; Coordinate all activities related to validations and/or testing, and directly… more
- zobility (Glen Allen, VA)
- …improvements for purchased materials and services. Communicates with field and project personnel to evaluate compliance with contracts. Compiles reports for ... Assists in maintaining contract databases and compiling information for project planning and forecasting. Requirements: Apply good business judgment Apply… more
- Spectraforce Technologies Inc (Atlanta, GA)
- Job Position: Medical Administrative Senior Representative (100% REMOTE) Duration: 3 Months Job Description: . The Administrative Support Specialist works under ... engaged teams. We have built our business by providing talent and project -based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to… more
- Rose International (Jacksonville, FL)
- …In addition, there will be many opportunities to partner with business leaders, senior HR leaders, and various Talent-related specialist functions (eg Learning ... Only qualified Project Managers with extensive Workforce Management experience located...documentation to communicate key conclusions and complex issues to senior stakeholders "Start-up mentality"- comfortable working with ambiguity and… more
- 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
- Teleflex (Morrisville, NC)
- Sr . Regulatory Affairs Specialist **Date:** Aug...the total cost of goods sold. The role of the Senior Regulatory Affairs Specialist is focused ... this dynamic, reduce costs, and enhance product margins. The Senior Regulatory Affairs Specialist will...to ensure all RA impacts are captured in each project . * Serve as RA lead in the team… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …skills. 7. Ability to comprehend technical documents and concepts. **External-Facing Title:** Senior Specialist Regulatory Affairs **Posting Country:** US - ... **12271BR** **Title:** Sr . Specialist , Regulatory Affairs...as sole representative from Regulatory to ensure regulatory compliance. + Depending on product/ project complexity,… more
- L3Harris (Palm Bay, FL)
- Job Title: Sr . Specialist , Construction Project Manager Job Code: 14759 Job Location: Palm Bay, FL Job Description: This (on-site) Facilities Project ... contractors and service providers, inspecting facilities to meet safety and regulatory compliance and managing building projects and renovations. They will… more
- Astellas Pharma (Westborough, MA)
- …Process Engineering, Supply Chain, and Manufacturing. The Senior Manufacturing Specialist typically reports to the Manager, Sr Manager, or Associate ... ** Sr Specialist , Manufacturing** Do you want...changes are in accordance with AGT's policies and procedures, regulatory requirements, guidelines, and recommendations. As assigned, will serve… more
- Vanderbilt University Medical Center (Nashville, TN)
- …and managing resources to bring about the successful completion of specific project goals and objectives. * Regulatory Documentation (Intermediate): Writes ... KEY RESPONSIBILITIES * Initiates requests for data analytics to identify potential regulatory risks. * Drafts and implements corrective action plans along with unit… more
- Astellas Pharma (Westborough, MA)
- …Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.** **Purpose:** The Sr Specialist , Manufacturing will be part of the Manufacturing team. ... ** Sr Manufacturing Specialist - Tech Transfer**...changes are in accordance with AGT's policies and procedures, regulatory requirements, guidelines, and recommendations. As assigned, will serve… more
