- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading ... the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the strategic direction to Biostats Data Mgmt & ... Reviews patient population and protocol compliance for consistency with study strategy ; Develops biomarker strategy in collaboration with Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC Lead of an early-stage project. He/she has responsibility for the overall strategy and status of the project with respect to budget, timeline, achievement of ... quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical issues,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …- enabling business success the Novo Nordisk Way by turning the Company's business strategy into an actionable workforce strategy . A strategy which captures ... the entire employee life-cycle. At Novo Nordisk, you will join an inclusive team of diverse talent and benefit from a range of possibilities for professional and personal development. Are you ready? The Position Responsible for providing consistent, high… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position As a senior member of the Advanced Analytics & Innovation Team (within Enterprise Data & Advanced ... projects managed elsewhere internally or at vendors. Relationships Reports to the Senior Director, Advanced Analytics & Innovation. Works closely across the entire… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …issues relating to major transactions. Typically advises SVPs, VPs, managers, associate directors and directors. Relationships Reports to VP of Intellectual ... agencies, law firms, trade organizations, and other external agencies. Interacts with senior management at NNI, headquarters, and/or other affiliates as required to… more
- Merck & Co. (Rahway, NJ)
- …with regional and local teams to support development and implementation of a sourcing strategy at a global level, leveraging a Supply Strategy Council (SSC) ... cross-functional teams through the sourcing process and to provide strategy oversight for regional and/or local components of the..."big picture" creation and it entails active engagement with senior stakeholders as well as critical members of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... strong and positive working relationship with OPDP reviewers. Report to Senior Director, Regulatory Affairs - Advertising & Promotion. Essential Functions Provide… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP) will be responsible for leading the Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and ... strategy , bridging the continuum from Discovery Research through Late-Stage...and collaboration skills, and executive presence to successfully engage senior leaders in governance meetings as well as the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... key internal stakeholders. In the execution of specific projects, the Associate Director, will be accountable for managing relationships with internal stakeholders… more
- Merck & Co. (Rahway, NJ)
- …strategy to keep them engaged and informed of the digital transformation.The senior specialist will report to the Associate Director, Stakeholder Engagement ... voice is valued, regardless of background or role. - Position Summary: The senior specialist, Stakeholder Engagement is responsible for analyzing the needs of key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships The Associate Director, Data & Analytics Governance reports to the Senior Director, Enterprise Data & Analytics Strategy . The role interacts on ... Are you ready to maximize your potential with us? The Position The Associate Director, Data & Analytics Governance is responsible for the governance of NNI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as ... Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality regulatory deliverables… more
- Merck & Co. (Rahway, NJ)
- …& Division organization of our company. - Position Description/Summary: - The GPAM Associate Director, Project Manager, is a core member of Early Drug Development ... the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive… more
- Merck & Co. (Rahway, NJ)
- …influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for tactical execution and has strong ownership & ... communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong negotiation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …department, ensuring projects follow project management best practices. Reporting to the Associate Director, E&C Program Strategy & Operations, this role ... supports NNI Ethics & Compliance systems and processes. Relationships Reports to the Associate Director, E&C Program Strategy & Operations. Works closely with… more
- Merck & Co. (Rahway, NJ)
- …in the execution of clinical studies.--Will report and work collaboratively with the- Associate Vice President to promote the development strategy of the company ... manage the entire cycle of clinical development, including development strategy , study design, initiation, execution, monitoring, analysis, regulatory reporting,… more
- Merck & Co. (Rahway, NJ)
- …of Biologics and Biopharmaceutics, have 10-15 direct reports composed of experienced, senior and associate scientists.- The successful candidate will effectively ... and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, and develop a team whose roles include design and… more
- Merck & Co. (Rahway, NJ)
- …Cell Based Sciences and will be responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position is ... accountable for developing integrated potency strategy and required analytical methods, including supporting assay transfer to GxP laboratories.- They will be… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists.- The successful candidate will ... Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy , lead activities, and develop a team that will build… more
