- Daiichi Sankyo, Inc. (Bernards, NJ)
- …thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings ... for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the full discussion for archiving. Serve as the primary contact with FDA.Lead and prepare FDA submissions, including but not limited to… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director , Key Accounts will shape, implement, and execute Key Account ... asset in hematology, EPKINLY. This critical role will report to the Director of Key Customer Strategy and be expected to work closely within the US Marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and interpersonal… 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)
- …collaborates closely with data manager to ensure high quality data.Drug Development Strategy : Provides input to multiple aspects of the development plan to ensure ... May participate in meeting or teleconferences with Health AuthoritiesGlobal BDO Strategy to Improve Drug Development: Primarily participates and may occasionally… 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 ... holders, and SMEs to build and execute an effective CMC development strategy .- Leads special project(s)/committee(s) that are critical to Compound development and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Business Process Manager, Global DX is responsible ... cross-functional BPM lead functions to implement and influence BPM strategy , including conducting process discovery workshops.Qualifications: Successful candidates will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in Corp. Functions so that they and Global DX develop a shared vision, strategy , and roadmap together from the beginning of discussion, and incorporate them into DX ... Global DX to ensure that technology solutions are aligned with the overall strategy and objectives of both the business and Global DXNeeds alignment between business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborates closely with data manager to ensure high quality data.- Drug Development Strategy : Provides input to multiple aspects of the development plan to ensure ... participate in meeting or teleconferences with Health Authorities- Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supports oversight and management of integrations solution design, implementation strategy and requirements gathering, and technical feasibility and delivery. The ... the highest possible business value, while subscribing to the enterprise IT strategy . Additionally, this role collaborates with technical and business leaders to… more
- Merck & Co. (Rahway, NJ)
- …Research & Division organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- Merck & Co. (Rahway, NJ)
- …drive technology optimization, align teams to overall Security and Compliance Strategy and drive technology and architecture blueprints re-use.The ideal candidate ... and define roadmaps and strategies, ensuring alignment with organizational strategy and company's goals.Stakeholder Engagement: Build and maintain strong… more
- Merck & Co. (Rahway, NJ)
- …ResponsibilitiesLead and set direction for the device development strategy for multiple drug-device combination product development programs ranging ... obstacles and effectively communicate complex product technical challenges, device development strategy , timelines, milestones, and risks within our Company and with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... and other key internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing relationships with internal… more
- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy , lead activities, and develop a ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development. Are you ready to maximize your potential with us? The Position The Associate Director , Data & Analytics Governance is responsible for the governance ... skills to ensure vision is maintained across various NNI functions. Relationships The Associate Director , Data & Analytics Governance reports to the Senior … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director , HCP Experience has overall strategic and operational responsibility ... About the Department The Strategy & Rare Disease (STARS) organization drives the...to the Hemophilia Therapy Area Lead. Works closely with Associate Directors and Sr Brand Managers across the Rare… more
- Insmed Incorporated (New York, NY)
- …strong related experience.Other Pharmaceutical experience - Medical Information, Medical Strategy , Clinical management/trial experience and 2 years clinical or ... research experience (non-pharma) is preferred. An excellent command of the English language. Effective presentation skills and advanced proficiency in interpersonal skills (listening, probing, persuasiveness, negotiation) are essential for engaging… more
