- Novo Nordisk Inc. (Plainsboro, NJ)
- …expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies for ... report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions Serve as a member of the...Essential Functions Serve as a member of the Global Project Team (GPT) utilizing precedent and experience to develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThe Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing ... leader of GPT. He/she will supervise the PJ Lead ADC/Bio#2 member and is the accountable for the...an integral member of the decision making in the Project lead .ResponsibilitiesDevelop/propose (or have subordinates) integrated CMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product development plan. This position is accountable for partnering with the Global Team leader as the Project Management lead on drug development ... supporting divisional and departmental level objectives and may also lead a non- project initiative in support of...in a biotech or pharmaceutical company.Demonstrated success as a project manager/ leader in planning and executing strategies… more
- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager serves as the primary program-level Global Clinical Supply point ... internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are looking for a Technical Project Manager to drive technical changes and work with appropriate internal and external stakeholders to help us ... to learn and execute and a self-starter.As a Technical Project Manager, candidate will play a key role within...set and pre-work for workshops is prepared and effectively lead discussions to ensure groups don't lose focus on… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The ... ensuring that these are well defined with measurable outcomes.- Product Line Lead , Workplace Services' primary responsibilities include, but not limited to :Vision… more
- Merck & Co. (Rahway, NJ)
- …Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, has primary responsibility for the ... group and in the field of m elanoma . The Executive Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be defined based on the project needs and the respective development stage of the project . The CMC Lead will support the Sr. CMC Lead on complex and/or ... late-stage project or act as main CMC Lead of an early-stage project . He/she has responsibility for the overall strategy and status of the project with… more
- Merck & Co. (Rahway, NJ)
- …in the role of Human Health Digital, Data and Analytics (HHDDA) Shared Services Lead . In this capacity, this role will help HHDDA realize the aspiration for the ... across the Globe. - Specifically, the HHDDA Shared Services Lead will:-- Shared Services Team Lead Serve...Collaborate closely with the Talent Enablement & Shared Services Leader to ensure the user adoption and overall effectiveness… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing ... involves efficient resource management, and clear communication with stakeholders and the project team. The Project Manager identifies and mitigates risks,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... across regions and functional areas. The role of the Global Process Lead involves developing and maintaining efficient, effective, and compliant business standards,… more
- Merck & Co. (Rahway, NJ)
- …of diseases in people and animals. In the capacity of a Global Labeling Lead , you will be instrumental in shaping the labeling strategy and ensuring the development ... you to demonstrate your superior execution skills.Core ResponsibilitiesAs a Global Labeling Lead , you will guide cross-functional teams in the creation, review, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Project Management Specialist as part of the Quality team based in Raritan, ... for identified continuous improvement efforts associated with the manufacturing site. Lead assigned Quality tasks associated with process improvements.Participate/facilitate in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support in the creation of business cases and the preparation of Kessai and/or Project Entrustment documentation for budget approvals. The Lead will also manage ... rare diseases and immune disorders. Summary The Non-Regulated Implementation Services Lead is responsible for the strategic oversight, planning, and execution of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project . Lead and prepare FDA submissions, including but not ... tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue and...the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Experience Architects, this role defines business requirements, manages project plans, and ensures alignment across stakeholders using workflow management ... Specification Manager role will report directly into the CX Specification Team Lead , within the broader Experience Operations function. This role will interface with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of emerging technologies and trends in the areas to provide informatics project management, SDLC Quality Model, subject matter, and computer system validation ... systems are inspection and audit ready. Overall accountability, ensuring higher quality project outcomes with optimal use of resources.- Provide such reports that… 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 ... agency partners and consultants (as a day-to-day contact) to manage project status, publication drafts, author comments, NNI reviews/approvals, and maintains… more
