- 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 ... project meetings.Provide guidance to peers and cross-functional team members regarding strategic regulatory issues.Develop timeline and strategic input… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ...Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input ... strategy globally will be preferred but not required.Experience in providing regulatory strategic input into the Oncology drug development preferred.Ability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry required.8 or More Years in regulatory affairsExperience in providing regulatory strategic input into the ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Merck & Co. (North Wales, PA)
- …and coaching to team membersContributes to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… 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 ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic … more
- Merck & Co. (Washington, DC)
- …reporting to the Executive Director , Policy Development & Strategy.The Associate Director will develop and maintain the strategic planning digital platform, ... Associate Director will conduct routine and ad-hoc analyses of individual strategic plans to inform GPP decision-making.The Associate Director will develop… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Merck & Co. (Washington, DC)
- …enterprise-wide engagement with policy stakeholders and influencers, serving as a strategic advisor to the Executive Director , Policy Development, Strategy, ... Executive Director in presentations for approval of positions to Strategic Policy & Sustainability Council.-Provide timely, concise, and accurate upward … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: 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
- Merck & Co. (Rahway, NJ)
- …AVP, Strategic Planning & External Engagement leadership team (LT) and Director , Strategic Operations Team to conduct regular, actionable analysis and ... Job DescriptionThe Executive Director , Policy Development and Strategy is a key...a key leadership role in the Global Public Policy Strategic Planning & External Engagement team, with responsibility for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: 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
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Associate Director , Policy Advocacy The Associate Director , Policy Advocacy serves as the senior expert in the Global Public ... policy change in support of the company's business objectives. The Associate Director will proactively research and stay abreast of new strategies and tactics… 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...both IIS and collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.Operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... research areas centered around rare diseases and immune disorders.Summary Provide strategic leadership for all statistical programming activity related to study,… 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
- 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
- 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...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... Essential Functions Innovation and change Identifies needs and opportunities for overall strategic changes in the culture and organization or in the way by… more
