- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global regulatory dossier generation and submission activities as a project manager . Support global project and submission teams ... diseases and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead...with project management expertise. Create and maintain regulatory project and submission plans, schedules, and… more
- Aequor (NV)
- …you are looking for? Biotech experience would be beneficial It's really experience as a project manager that is important What type of key words stand out for ... and Workforce Strategy program that currently consists of the E2E Regulatory Content Automation and Regulatory India initiatives. Additional initiatives… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.) Works directly with Regulatory Project Mangers to prepare labeling items consistent with content ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...submission planning meetings to ensure clear communication of the project plan, actions items, risks, and decisions to the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Project Manager II is responsible for managing larger, more complex projects or multiple projects simultaneously. This role focuses on ... and implementing project strategies, and ensuring alignment with business objectives. The Project Manager II serves as a key contributor to the organization,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Project Manager I supports the management of small to medium-sized projects or programs, ensuring they align with business objectives and ... and resource coordination while working closely with cross-functional teams and leadership. The Project Manager I is responsible for being in compliance with all… more
- Merck & Co. (Rahway, NJ)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager serves as the primary program-level Global Clinical ... clinical and development related meetings.- Working independently, the Program Clinical Supplies Project Manager designs strategic and operational plans for all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in ... NJ. Role OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy… 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-of our Company marketed products . Analyzes and anticipates project risk s as they relate to clinical supply… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: - The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & ... organization of our company. - Position Description/Summary: - The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …projects independently and supports larger, more complex projects under the guidance of a Project Manager . The Project Coordinator is responsible for being ... manage small projects and support larger projects under supervision.Develop project schedules, track budgets, and coordinate cross-functional team efforts.Identify… more
- Merck & Co. (Durham, NC)
- …concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and ... finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Participates in cross-functional project teams locally and/or globally May act as a project leader with own manager oversight Has the ability to identify and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...you ready to make a difference? The Position The Manager - Publications works with minimal direction from a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical… more
- Genmab (Plainsboro, NJ)
- …Supply Manager , of the following tasks:Global Clinical Drug Supply Project /Trial ManagementObtain Project /Trial specific information to initiate drug supply ... functional collaboration (ie, project /program and trialsLead/Participate in Clinical Project Supply Team discussionParticipate in regulatory discussions in… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Maintenance/Calibration Manager is a leadership opportunity within the Engineering/Maintenance team supporting a new drug substance manufacturing ... on the team through actions, coaching, and prioritization Participate in safety/ regulatory audits (ie tours, topic discussion) Coach individuals when reporting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... attain resources and information from established internal contacts; consult with manager for decisions outside of established procedures.Provide direction to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …time to understand business goals, strategies, emerging risk areas, and the regulatory landscape, ensuring ability to serve as a knowledgeable and effective ... required A minimum of six (6) years combined pharmaceutical, human resources, legal, regulatory , and compliance experience required OR a minimum of four (4) years'… more
- Aequor (Thousand Oaks, CA)
- …within R&D. Experience in training within R&D. Background in clinical research, regulatory affairs, and research and development training in the biotech industry. ... deliver and execute on a vision/strategy. Not looking for administrative or project coordinators. Not looking for general training and learning developers (eg, LIMS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drive and shape the quality landscape across regions. This may include assessing regulatory intelligence and industry best practices and sharing with the BPQLs and ... activities, which prioritize and focus on the delivery and execution of non- project initiatives within R&D Quality and Global RD/PV QA by collaborating with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Accounting at Novo Nordisk Inc. As part of the NNI Finance team, the manager will business partner with budget controllers (FP&A) and other key stakeholders across ... teams regarding the identification and impact assessment of new regulatory issues and the planning of audit timing and...seldom gives up before finishing a difficult or cumbersome project Team Approach - cooperates with everyone to achieve… more
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