- Daiichi Sankyo, Inc. (Bernards, NJ)
- …improve or optimize organizational efficiency and decision making.Responsibilities: Project ResponsibilitiesIndependently manage or lead strategy development ... Project Team(s) in partnership with the Global Team Leader to drive strategy development and create an integrated...influence and mentor more junior PMs, Team members and project stakeholders.As a TA lead or … 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process ... updating relevant Trial Master Files (TMF) with CSO-related documents.Supports the CSO Project Mgmt Lead in executing additional operational and logistical… 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
- 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
- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.-.... - At least 8 years of experience in project management . - - At least 5 years… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities and interdependencies for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross-functional Clinical ... resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader .Ensure adherence to internal procedures for… more
- Merck & Co. (Rahway, NJ)
- …departmental projects related to regulatory operations. This role will establish project plans, monitor progress, coordinate resources, and ensure timely completion ... of project deliverables. Will also be responsible for supporting all...enhance efficiency and streamline regulatory operations processes. Also take lead or help lead process improvement initiatives,… more
- Merck & Co. (Rahway, NJ)
- …the development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.Maintain a high level ... device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible ... for providing operational excellence project management support to the cGMP Clinical and Commercial...experience working and leading in a matrix environmentAbility to lead with influenceAble to manage shifting priorities to meet… 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 breast cancer. The Executive Director, PDT lead will manage the entire cycle of clinical development, including development strategy, study… more
- Genmab (Plainsboro, NJ)
- …own products across various markets within cancer treatment.We are now looking for a Clinical Project Lead (CPL) to join the team, who will be responsible for ... input into the Clinical and Compound Development Plans developed by the CDT. Lead and coordinate cross functional Development Operations input and ensure unified… more
- Merck & Co. (Rahway, NJ)
- …(SMAR&D) group has an exciting opportunity for a director role as Strategic Operations Lead based in Rahway, NJ. As the Strategic Operations Lead within the ... Demonstrated technical or operational leadership with significant and measurable project impact. Demonstrated ability to develop talent through good mentoring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for monitoring the activities per the Business Plan and priorities.Support Team Lead to manage GOMA project /activities, including ensuring that the GMAT/Function ... the assigned Global Medical Affairs Team (GMAT) or Functional Lead , and the Franchise or Function Head to deliver...in collaboration with GMAT/Function team, and develop a detailed project plan in order to track progress and measure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the needs of the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and site qualification discussions, kick-off meetings ... around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH, clin pharm… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery ... cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …embark on shaping our future. The Position The purpose of the Speaker programs lead is to advance knowledge in the rare disease community. This role is responsible ... pre- and post-launch engagements. Relationships Reports to the Portfolio Strategy Lead in the Rare Disease Commercial Strategy and Marketing organization. Essential… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …we embark on shaping our future. The Position The Rare Disease Conventions Lead plays a pivotal role in advancing knowledge and fostering industry engagement within ... support of rare disease patients. Relationships Reports to Rare Disease Portfolio Strategy Lead and is key contributor to the Rare Disease Commercial Strategy and… more
