- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of ... research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on ... product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...often works with ambiguity and complex problems, focusing on strategic and operational decisions.ResponsibilitiesActs as point of contact for… more
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... and coaching to team membersContributes to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... both IIS and collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.Operational Strategy:… more
- Merck & Co. (North Wales, PA)
- …We are currently recruiting for someone to join our US marketing team as the Associate Director , Product Marketing Owner - HCC / Ecosystem for the HIV Franchise. ... ownership of brand and HCC strategy and execution. This position will report to the Director , US Commercial Leader (USCL) and will be based in the Upper Gwynedd, PA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for a specific set of R&D categories (CRO, Medical Writing, BDM, etc..). Builds strategic plans for specific categories under the direction of the head of category ... projects through established interactions with Japan and Europe as required. Demonstrates strategic foresight and thought when approaching tasks and ensures that all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director , Alliance Management.Tris Pharma has a long track record of ... spanning many departments across all stages of the product lifecycle. The Associate Director , Alliance Management will be accountable for managing alliances… more
- Merck & Co. (Rahway, NJ)
- …of regulatory environment, and vision to influence the regulatory environmentWill be responsible for sub-functional strategic planning, coordinating, ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Insmed Incorporated (San Diego, CA)
- …to the Executive Director of Program Management, the Associate Director , Program Management supports the cross-functional drug development ... project plans for products in accordance with the program strategy. In addition, the Associate Director of PM may be asked to lead and/or participate in… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development ... of developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program.… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical Development ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of… more
- Merck & Co. (Rahway, NJ)
- …of regulatory environment, and vision to influence the regulatory environmentWill be responsible for sub-functional strategic planning, coordinating, ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director , HCP Marketing is responsible for developing and implementing strategic ... with co-promotion partner, agencies and internal business partners; ensuring regulatory /legal requirements are met. Essential FunctionsSummary of Job Responsibilities:… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of ... and external CMO sitesDrive new process version plans and content for regulatory submissionsEnsure global records are consistent and maintained to achieve consistent… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Eisai, Inc (Raleigh, NC)
- …reference standards to support product portfolio.Responsible for developing and maintaining strategic relationships with other Eisai units, technical leaders in QC, ... and approve relevant technical documents, such as change controls, regulatory submissions, deviations, validations, method transfers, APRs, etc. as… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion of the… more
