- Insmed Incorporated (San Diego, CA)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Program Management , the Associate Director , ... in special department, cross-functional, or team projects. The Associate Director of Program Management will...Project/ Program Management experience with proven management and/or leadership experience in an R&D, Regulatory… more
- Tris Pharma (Monmouth Junction, NJ)
- …the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. The Executive/Senior Medical Director ... to Pain programs and assists, as appropriate, in other therapeutic area program development (ie, substance use disorders, ADHD, etc.); Designs and implements… more
- Merck & Co. (Rahway, NJ)
- …development and characterization, scale-up and activities to support technology transfer and regulatory filings. They are responsible for the management and ... management duties.Through their leadership and strategic guidance, the Director will ensure that their interdependent and multidisciplinary team develops and… 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 &...and shaping scientific strategy both at the platform and program level.Project management and/or scientific over-sight of… more
- Merck & Co. (Rahway, NJ)
- …concepts and solutions considering competitive factors, market demand, risk management , program economics, strategic fit, and operational complexity.Identify ... results.Have broad experience in Animal health commercial operations, R&D, and Regulatory Affairs-Expertise in project management , business adoption/change … more
- Merck & Co. (Millsboro, DE)
- … inspections (USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for animal welfare, management of… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and external ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position Drive study management activities and manage cross-functional study team, external service… more
- Merck & Co. (Rahway, NJ)
- …applying regulatory frameworks and keeping abreast of the changing regulatory landscape.Strong leadership, change execution, and financial management skills ... Job DescriptionPosition Description: Director , Product Stewardship Our Global Safety & Environment (GSE) team is passionate about bringing our medicines and vaccines… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Global Commercial Program Head as part of the Technical Operations team based in Somerset, New ... is a key member in the global MSAT organization. This individual will be a program lead / owner for a best-in-class high volume marketed CAR-T product as part of… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management , CMC and Regulatory Affairs teams. ... with the VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management , CMC and Regulatory Affairs teams… more
- Eisai, Inc (Nutley, NJ)
- …compliance requirements across relevant jurisdictions.Update IT compliance policies based on regulatory changes.Establish a regulatory change management ... to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and enhancing globalization at DS QA-GMP affiliates. Proactively supports Global QA CMO Management and Global QA Audit Program teams.Responsible to ensure that ... and collaboration with Global External Supplier QA teams.Collaborate with Global Quality Management System (QMS) teams on regulatory -related CAPAs that impact… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, maintenance, ... of the CDISC (SDTM, ODM.XML, CDASH) industry standards, Metadata management and Data Mappings and are some of the...of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU &… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Director is responsible for developing RWE strategies for assigned product(s) and execution of RWE ... vendors selected to manage ongoing RWE efforts, including Ph4 study management , and presentations and publications emanating from these effortsDrive ongoing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …throughout the US affiliate and globally if needed; responsible for administrative and management support of field-based FMA Program at Novo Nordisk Inc (NNI). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...all laws, regulations and policies. Responsible for administrative and management support of field-based FMA Program at… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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...with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and other RD functions… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …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 ... therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy... to lead our in vivo CAR-T cell therapy program . If you're passionate about advancing groundbreaking treatments and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety ... areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
