- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of PJ Lead and Tech Unit.- Provides leadership in the project/development team , as Matrix Lead , interfacing with various site locations globally and on ... research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …bodies.Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader .Ensure adherence to internal ... plans.Monitor study budget against trial progress and bring deviations to the Operational program Lead and study team leader . Review and approve Vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Merck & Co. (Rahway, NJ)
- …development, and validationSelf-motivated with ability to work independentlyProven ability to lead team members of diverse skill sets and backgroundsStrong ... Job DescriptionOur company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled… more
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, has ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and ... areas centered around rare diseases and immune disorders. Summary: The Associate Director, Regulatory Affairs - Regulatory Project Management (RPM) provides planning… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling ... serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Merck & Co. (Rahway, NJ)
- …and lead strategic and process improvement initiatives to drive team efficiency and effectivenessMaintain up-to-date knowledge of trademark industry rules and ... Position Description: The Office of General Counsel is seeking an Associate Director, Trademark Operations to provide docketing and legal operations support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Principal Statistical Programmer - Oncology (Hybrid) In BARDS (Biostatistics and Research Decision Sciences), a ... programming analysis and reporting deliverables for global stakeholders. The Associate Principal Programmer will gather and interpret user requirements for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Process & Product Modeling Team in our Company Manufacturing Division seeks an experienced Associate Principal Scientist who will develop and ... in solving complex, physical/biochemical problems faced during industrial manufacturing. Lead the development and deployment of computational tools, using a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …capture the full discussion for archiving. Serve as the primary contact with FDA. Lead and prepare FDA submissions, including but not limited to briefing documents, ... therapy designation requests, orphan drug applications.Participate in global product team meetings (development and marketed products); provide regulatory support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the identification, coordination assessment, ... meetings; leading negotiation sessions in concert with senior GBD Transactions team members; and alliance management participation following successful completion of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …program for DSI, for DS products and alliances. Cultivates a high performing team by coaching and developing as they support all strategic sourcing responsibilities. ... policies and methodologies are understood and utilized. Serve as the lead "relationship manager" to proactively deliver strategic sourcing insights, optimal value… more
- Merck & Co. (Rahway, NJ)
- …The Pharmacometrics group within QP2 brings an experienced leadership team , deep modeling expertise and state-of-the-art modeling approaches across multiple ... and modalities to drive portfolio impact from discovery through life-cycle management. The team is externally visible and continues to be at the leading edge of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and life-cycle ... Therapeutic Area (CV&R). The incumbent will be expected to lead multiple programs including those new to the organization...They will also be responsible for guiding Product Development Team Leaders and Clinical Directors within their group to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, ... and peers. Experience directly supervising employees is preferred.Ability to work with and lead others in a team environment.Demonstrated ability to develop and… more
- Merck & Co. (Rahway, NJ)
- …the organization to support our patients and customers worldwide. Our team comprises energetic and innovative individuals dedicated to leveraging information and ... company's global impact on medical innovation.The objective of the Technical Capability Development team is to develop the full potential of our people through deep… more