- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... Years Experience in the pharmaceutical industry7 or more years with direct regulatory affairs experienceExperience in regulatory submissions in… more
- Merck & Co. (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... performance against metric targets.Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own.Lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. ... Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback from the… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline coordinates the development and implementation of the Global Medical ... edge of therapeutic and patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …state government affairs strategy and engagement. Contributes to internal and external advocacy and educational materials and provides support to leadership in ... around rare diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement… 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 ' externally sponsored clinical research (ESR) initiatives, ensuring strict...the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) projects. Candidates should have a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan,… more
- Merck & Co. (Washington, DC)
- …(AI), climate and environment, manufacturing localization, and supply chains.Additionally, the Director will represent our Company in external working groups ... Job DescriptionPosition Description: Director , Policy Development The Director , Policy...current above-product policy realities are built into -internal and external decisions with the potential to impact our company.The… more
- Merck & Co. (Washington, DC)
- …policy advocacy materials and resources and direct the work of internal and/or external vendors to improve usability. The Associate Director will identify ... Job DescriptionPosition Description: Associate Director , Policy Advocacy The Associate Director ,...The role reports to the AVP, Strategic Planning & External Engagement, and directs the development of innovative advocacy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...on-boarding and provide on-going support, as determined by Field Director Ensure personal compliance with all internal/ external … more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be… more
- Merck & Co. (Washington, DC)
- …of strategic planning and policy development across the Strategic Planning & External Engagement team, reporting to the Executive Director , Policy Development ... Job DescriptionPosition Description: Associate Director , Policy Strategy and Capabilities The Associate Director , Policy Strategy and Capabilities is… more
- Merck & Co. (Rahway, NJ)
- …plans and develop a global view of policy priorities for GPP. The Executive Director will direct development of internal and external policy positions on ... across the policy function and work with the AVP, Strategic Planning & External Engagement leadership team (LT) and Director , Strategic Operations Team to… more
- Merck & Co. (Rahway, NJ)
- … may:Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... 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… more
- Insmed Incorporated (San Diego, CA)
- …internal (Marketing, Sales, Manufacturing, Market Access, Patient Services, Regulatory Affairs , R&D, and Legal) and external (healthcare professionals, data ... team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, clinical quality, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and interact with key external experts, ... will interact with the Companion Diagnostics Lead, Non-Clinical Research, Medical Affairs and other stakeholders to support the program. Other responsibilities will… more
