- Formation Bio (New York, NY)
- …oversight of pre-clinical and clinical-stage large molecule asset acquisitions and lead analytical activities at contract development and manufacturing ... provide technical leadership for all analytical activities at CDMOs and contract laboratories (routine testing in support of manufacturing, method development,… more
- Formation Bio (New York, NY)
- …and regulatory documents to support drug development programs. Experience as lead writer for key clinical and regulatory documents required. Experience mentoring ... or managing other writers (internal or contract ) preferred. Understanding of FDA/international regulations, ICH guidelines, and applicable US/international… more
- Merck & Co. (Rahway, NJ)
- …bank manufacturing, both within our Company network and at contract manufacturing organizations (CMOs).-Author required regulatory and technical documentation ... and sustain technical standardization of best practices across the network. Lead assignment execution against accelerated timelines, in a right-first-time manner,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the methodology, approach, and… more
- Merck & Co. (Rahway, NJ)
- …-The primary responsibility of the Deputy Chief Privacy Officer is to lead the team responsible for internal and external stakeholder engagement, working in ... close partnership with the operations lead .Specific responsibilities include:Oversee the team of Regional Privacy Leads and privacy professionals who engage directly… more
- Merck & Co. (Rahway, NJ)
- …Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply: ... Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External… more
- Merck & Co. (Rahway, NJ)
- …cell bank manufacturing, both within our Company network and at contract manufacturing organizations (CMOs).-Monitor cell bank process performance across programs, ... tight timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …o Provides regular updates for Brand Teams and Senior Management on contract performance issues, including over- and under-performing contracts o Analyzes ... Novo Nordisk's top PBM/payer accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to...position. Apprises senior leadership of key risks of major contracts . Successful contract negotiation is vital to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the main point of contact to the Dx partner for CDx project contracts . Supports CDx analytical and clinical validation studies in collaboration with Dx-partner ... Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role is responsible for partnering with DS internal senior stakeholders to lead , assess, develop, negotiate, and execute strategic sourcing activities (both US and ... Global) from RFP through to contract execution.Leads all aspects of strategic sourcing to ensure...and methodologies are understood and utilized. Serve as the lead "relationship manager" to deliver best practices to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …partners and vendors' performance through appropriate metrics. Negotiate and executes contracts / SOWs and budgets for desired services Physical Requirements 10-20% ... that have high ROI Agency/Vendor management experience required Ability to lead and collaborate on cross-functional teams required Anticipates problems and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Partners with PCOR and MAPA teams to provide scenarios in predicting contract change impact. Helps Associate Director, Market Access Insights in creating market ... deliver actionable managed markets insights is required Ability to lead without authority/reporting relationship required Analytical and/or technical proficiency at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position requires demonstrated line management experience and the ability to manage/ lead people and a variety of projects concurrently. Additionally, this position ... aligning with Daiichi Sankyo and regulatory requirements.- Participate in vendor contract and MSA discussions, strategic vendor selections, and bid defense… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO ... when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies as well as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated study plan and create ... initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO selection process and provide input into ARO selection.Validate the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …of Authority (DOA) and procurement guidelines. The IT Contracts and Assets Lead will also ensure timely contract renewals, conduct thorough reviews of MSAs, ... Description: The IT Contracts and Assets Lead serves as...IT, Finance, and Procurement to streamline procurement processes. + Contract Management Oversee all stages of vendor contract… more
- Honeywell (Morris Plains, NJ)
- As a Contracts Lead , you will handle all facets of contract formation and contract management including drafting, interpretation, negotiation, ... also be responsible for helping design and enforce commercial contract policies and processes and serve as a focal...operations. By effectively managing and overseeing the execution of contracts , this role will ensure that Honeywell operates in… more
- BAE Systems (Totowa, NJ)
- …moderately complex contracts under the general guidance of the SFFS Contract s Director and/or LRASM C3 Development Senior Manager. Actively participate and ... **Job Description** Job Description Join a dynamic Contracts team that supports the delivery of mission critical capabilities across a diverse portfolio of… more
- City of New York (New York, NY)
- …one (1) Administrative Contract Specialist to function as Director of Expense Contracts who will; - Oversee the day-to-day operations of the Contract ... Tracking Unit (CTU) staff, responsible for procuring DHS service contracts . Review contract proposals and performance reports to ensure compliance with the… more
