- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans ... Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address...non-our company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply… more
- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... Areas, Portfolio Management, Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Senior Manager , Patient Support Data Intelligence is responsible for process improvement, ... other documentation to assist with audits and inspections, both internal and by regulatory authorities Design, develop and manage tools which are being used to… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (North Wales, PA)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM,… more
- Genmab (NJ)
- …the above by developing and writing corresponding SAS or other programs. The Senior Programming Manager may also serve as a compound lead.Responsibilities/tasks ... for Programming Manager , at least 6-8 years of experience for Senior Programming ManagerHas experience working in a global contextProficient in both written and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance. External relationships ... Responsible for the compilation and processing of pharmacy redemptions for Senior Management approval Oversees vendor performance via regular status meetings,… more
- Merck & Co. (North Wales, PA)
- …Global Regulatory Affairs.--The AVP provides leadership and direction through senior -level and first-line managers and statistical staff focused on end to end ... teams both as a direct manager and a second line manager (ie, managers of managers)Demonstrated collaboration with senior cross-functional leadership in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and ... controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Merck & Co. (Durham, NC)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... least three (3) years in direct management of shop floor production activities. Project Management - Proficient with Project Management and Virtual Collaboration… more
- Stryker (San Jose, CA)
- …the creation of detailed Work Breakdown Structure.* Contribute to the detailed project Gantt chart. Collaborate with PM on major workstreams, and intersecting ... of responsibilities may be added as deemed necessary by the local hiring manager .* Shows care and concern about team members, regardless of background, and creates… more
- AECOM (Rocky Hill, CT)
- …to develop professionally through frequent collaboration with senior engineers, project manager , clients, regulatory agencies, and industry-leading ... + Work under supervision of a project manager in the water/wastewater/water resources practice or senior...+ Ability to communicate and coordinate with clients, subconsultants, regulatory agencies, and members of the public as may… more
- State of Georgia (Fulton County, GA)
- … Manager / Senior Project Manager Georgia - Fulton - Atlanta (https://ga.referrals.selectminds.com/jobs/64025/other-jobs-matching/location-only) ... facilities. The Project Manager also performs other job-related duties as assigned. Senior Project Manager : Under broad supervision, the Senior … more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the ... Senior Manager of Regulatory Operations is responsible for...to publish and dispatch health authority submissions. + Represents Regulatory Operations on project teams for matters… more
- Southern California Edison (Rosemead, CA)
- Join the Clean Energy Revolution Become a Senior Manager of Regulatory Dam & Public Safety at Southern California Edison (SCE) and build a better tomorrow. ... regulatory compliance? Join our team as a Senior Manager for Regulatory Dam...improving execution efficiency + Leads, manages and supports the project engineering group and remains responsible and accountable for… more
- Deloitte (Sacramento, CA)
- Financial Services Senior Manager - Regulatory & Financial Risk Our Deloitte Regulatory , Risk & Forensic team helps client leaders translate multifaceted ... on November 30, 2025 Work You'll Do As a Senior Manager , you will have opportunities to:...regulatory , risk-related, technological, or operational evolutions + Strong project / program management skills, particularly possessing a strong… more
- Abbott (Sylmar, CA)
- …of device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management ... CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is...outcomes of initial product concepts and provide input to senior regulatory management + Assist in the… more
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