- 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)
- …wallets.Proven track record in vendor management, strategic planning, and regulatory compliance.Strong analytical, negotiation, and project management ... Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation of the credit union's payments… more
- Merck & Co. (North Wales, PA)
- …Identifying Risks, Life Science, Medical Writing, Motivation Management, Prioritization, Project Management, Regulatory Compliance, Regulatory Documents, ... skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials.Job… 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
- 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)
- …team. You will build and coach your team in the development of project management, communication, and collaboration skills in support of our clinical trials.Job ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- BioAgilytix (San Diego, CA)
- …analysis.Write and review reports and prepare SOPs.Fulfill the role of Bioanalytical Project Manager (BPM)/Principal Investigator (PI) for all assigned clients ... you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... programming efforts of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical… more
- Merck & Co. (Rahway, NJ)
- …the disposition of API materials to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory ... our Company procedures.- The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs and our company's procedures to assure API manufacturing… 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
- Merck & Co. (Rahway, NJ)
- …(e . g . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with ... clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and...Degree +5 years of pharmaceutical , clinical drug development, project management , and/or medical field experience OR Master… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management ... controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through senior-level and… more
- BioAgilytix (Durham, NC)
- …(LC/MS) team is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical ... that shape the future of healthcare.Essential Responsibilities:Serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects… more
- Merck & Co. (Durham, NC)
- …guided by policies, procedures and business plan; receives limited guidance from manager .Prepares routine PMs for execution and ensures materials, tools and permits ... Skills: Strong planning, scheduling, and time management skillsFamiliarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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, ... and related processes, policies, regulatory requirements and ICH guidance.... requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, organizational,… more
- Novo Nordisk Inc. (Durham, NC)
- …equipment for the core processes to meet all customer, business & regulatory requirements through the following activities: People Focus, Process Focus, Equipment ... Focus & Standards "Gatekeeper". Relationships Reports to Manager , Technical Support. Essential Functions Coach & mentor peers, Engineering personnel & Process… more
- Insight Global (Denver, CO)
- Job Description Insight Global is looking for a Regulatory Project Manager in the Great Denver area. This individual will be responsible for oversight on ... regulatory filing projects. In this role you will be...external stakeholders, track and monitoring deliverable schedules, assist in regulatory filing document build outs and assist in building… more
