- Daiichi Sankyo, Inc. (Bernards, NJ)
- …governance processes, and on Joint Alliances.Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of ... project meetings.Provide guidance to peers and cross-functional team members regarding strategic regulatory issues.Develop timeline and strategic input… more
- The George Washington University (Washington, DC)
- I. JOB OVERVIEW Job Description Summary: The Director , Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance (AP-RIC) ... administrative oversight of the research radiation and laser safety programs. The Director , Regulatory Oversight works closely with Office of Research Integrity… more
- ITS Con Global (Fort Worth, TX)
- OverviewThe Director , Safety and Regulatory Compliance is responsible for the successful development, implementation, maintenance, communication and training of ... an effective Safety program , to include accident and incident investigations, data analysis...and other state, local or industry specific regulations. The Director , Safety and Regulatory Compliance will manage… 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
- 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
- Merck & Co. (Washington, DC)
- … program effectively and efficiently.Contribute to quarterly and annual strategic planning and evaluation processes for the GPP organization. Position ... Job DescriptionPosition Description: Associate Director , Policy Advocacy The Associate Director ,...capabilities, and policy messaging assets for GPP's and market-level strategic policy engagement. The role reports to the AVP,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Tris Pharma (Monmouth Junction, NJ)
- …from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior Director , Head ... development and execution of brand marketing strategiesLeads and participates in strategic and operational creation and implementation of annual strategic … 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 ... in the treatment of multiple myeloma.Legend Biotech is seeking Global Commercial Program Head as part of the Technical Operations team based in Raritan,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' ... both IIS and collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.Operational Strategy:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This Clinical Science (CS) Group ... Lead will be responsible for overseeing multiple program -level CS Asset Leads who are managing a team...RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs, and other RD functions to ensure effective… more
- Merck & Co. (Rahway, NJ)
- …and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will collaborate with global, cross functional team members including ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for ... more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible for managing the… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of ... in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team based in… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead ... & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation ... of developmental and regulatory strategy; Drafts protocol profiles and sections of key...For large or complex Phase 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation ... of developmental and regulatory strategy; Drafts protocol profiles and sections of key...For large or complex Phase 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …needs and KPIs Develop a comprehensive marketing strategy, plan, and program architecture, supporting each partnership's business priorities, with the goal of ... partnership and driving value for stakeholders Supplier relationships: Drives Strategic Sourcing for Therapeutic Areas and Commercial needs: Identify, evaluate,… 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 ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical Operations team based… 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. Responsibilities Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit… more
