- Tris Pharma (Monmouth Junction, NJ)
- …status updates, mitigation strategy/plans, escalation of issues for trial or program level deliverables to senior management, etc.); Develops, implements, ... an immediate opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations.The Senior Director, Clinical Operations provides expert… more
- Catalent (St. Petersburg, FL)
- I. Department Overview: The Quality Assurance Department is responsible for providing leadership and support to the Catalent St. Petersburg site. The Department has ... the responsibility for Quality aspects related to Quality Systems, Finished...in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing and prioritizing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …drives, and manages an effective, holistic continuous improvement, problem solving and project management program to improve safety, compliance, cost, process ... an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr . Manager of Operations - Continuous Improvement and Projects as part of the… more
- Aequor (Thousand Oaks, CA)
- …the top end of the experience level. Ideally candidates who have strong project management experience as well as product development experience (Have skills such as ... directors and have the ability to present themselves well.* 6&plus years of project management experience - Pharma familiar with Deviation & CAPA processes. Ability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and focus to agreed strategy; Coordinates clinical activities across the project ; Represents IPT to Sr . ManagementAdditional non-study related activities: ... and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Merck & Co. (North Wales, PA)
- …safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with ... timely and high quality deliverables. For assigned projects the position serves as...departmental SOPs and good programming practices.Maintain and manage a project plan including resource forecasting.-Coordinate the activities of a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …review of NNI internet site and its waterfall of content Manage project vendor partners, budgets, schedules, testing and quality components Participates ... of record to implement new programs. Healthcare Professional Omnichannel Program Development, Implementation, Promotion and Monitoring: Assure compliance with Novo… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... contractors, IT, metrology & other key stakeholders to ensure the right quality , cost & timely completion of all validation deliverables. Relationships Associate… more
- Insmed Incorporated (Bridgewater, NJ)
- …in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines, government regulations, etc.Provides operational support for ... of site and sponsor training (eg, study specific, drug, program , and therapeutic area level), and maintains training matrices...the Sponsor‐ and CRO‐supported TMF at intervals specified in project plan and/or applicable SOPs and/or prior to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that ... facilitates Health Authority reviews.- Supports company`s GMP Change Management Program . Evaluates CMC changes for portfolio biologics and determines filing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently and proactively represented at program level and along ... point person for all GxP matters for the Global Program Head and the Global Program Team....components for the designated programs. Ensure proactive representation of Quality professionals at strategic project team and… more
- Merck & Co. (Rahway, NJ)
- …the clinical data management strategy for assigned trials within a specific drug/vaccine program .- Develops and manages project plans which span from protocol ... to align resources and ensure all aspects of the project plan are executed on time and with appropriate... plan are executed on time and with appropriate quality .- Agrees/arbitrates deliverable-based commitments based on detailed knowledge of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development experience ideally including time in role such as a Global Project Leader at Sr . Director level or equivalent preferred- Relevant therapeutic ... clinical trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role...a key point of escalation for issues impacting across program for both internal and external stakeholders. Responsible for… more
- Merck & Co. (Rahway, NJ)
- …engagement, and stakeholder management, you will collaborate with cross-functional teams, senior stakeholders and our supplier network. You will lead the category ... and leverage strong communication skills and program management expertise to rapidly adapt and...the sourcing of carbon offsets annually from 2025 through project development, forward purchasing, and spot market purchases.Supports our… more
- Merck & Co. (Rahway, NJ)
- …development, and/or engineering and regulatory science.Proven ability to lead program development teams using project management skills.Preferred Experience ... across the organizations (Research Division/Manufacturing Division), such as Analytical, Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo, ... the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key… more
- Merck & Co. (Rahway, NJ)
- …clinical siting and compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program ... a matrixed reporting relationship to functional groups in development, quality , safety, facilities management, analytical, finance and regulatory.-FLEx was designed… more
- Merck & Co. (Rahway, NJ)
- …site program such as Manufacturing, Research, Tech Ops function, Quality or EHS Plant Leadership in pharmaceutical or chemical industryRobust skills interpreting ... in some 150 markets.Accountable for all Environmental, Health, and Safety (EHS) program execution and compliance at our Manufacturing Division's Animal Health Sites… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, ... clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study… more
