- 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)
- …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
- 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
- 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
- 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
- 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
- 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
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... 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… 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
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.Job Summary The Director is responsible for developing strategies for assigned product(s) and execution of HEOR and ... products, interfaces with cross-functional teams including marketing, market access, and medical affairs to align strategies, and partners with HEOR field team in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …industry experience (including roles in research and development (R&D), clinical trials, regulatory affairs , or medical affairs Leadership Experience: Proven ... right medical and scientific innovation level to ensure M&S area is a strategic partner in the projects and clinical drug development activities. This includes… more
