- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...(NNI) and Novo Nordisk A/S (NN) to drive successful project outcomes for assigned projects. Develops and maintains positive… 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work in a growing ... Independently manage interactions with clinical monitors, data management, safety, regulatory , pharmaceutical science and QA team members, both internally and… 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
- 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
- Aequor (West Chester, PA)
- …experience in Presentation skills (presenting Dashboards, etc). o 5&plus years of project management experience. o 5&plus years of experience in strategic operations ... Background 2. Drug 11 panel with Fentanyl Job Title: Strategic Operations Manager - Global Health Economics, Value and Outcomes (GHEVO) Department: Global Health… more
- Aequor (Thousand Oaks, CA)
- …management knowledge of full product manufacturing stages experience. The Supply Chain Project Manager (SCPM) will translate product variation strategy as ... This role will own the execution of the implementation plan in terms of project management and change control execution. This role will apply project management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to maximize your potential with us? The PositionThe Manager of Master Data will work within the Master Data Team and will have ... and enhancement of Data Governance directives resulting from market and/or regulatory changes for Master Data Domain Responsible for the addition, expiration,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The HCP Manager will be a critical driver in driving engagement within field teams by overseeing the ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Field Promotion Content: Develop creation of… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Manager has responsibility for the QA oversight of manufacturing build up ... and / or pre-commercial product.Manage the quality aspects of clinical project from raw materials to manufacturing to packaging, distribution and releaseFocus… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position As the general project manager for Patient Support Solutions, the role focuses on not only leading ... team Serve as the Compliance and Legal lead, ensuring adherence to regulatory standards and integrity across all PSS programs. Physical Requirements 0-10% overnight… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and variances that occur during production or validationWork with Quality, Manufacturing, Regulatory , and subject matter experts to prepare for FDA and other agency ... assigned Required Skills:Must have exceptionally strong communication, interpersonal and project management skillsAbility to multi-task and methodically manage projects… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …fields is preferred A minimum of eight (8) years combined pharmaceutical, legal, regulatory , and compliance experience required OR a minimum of six (6) years' ... lifecycle and compliance requirements of post-acquisition timelines Ability to project manage multiple projects to completion meeting internal and external… more
