- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Merck & Co. (North Wales, PA)
- …the development and implementation of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is...for stakeholders as needed.Build and maintain excellent relationships with clinical investigators, scientific leaders, external authors, journal editors, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and HQ counterparts to promote quality and consistency across regions. Ensure compliance with SOPs, KPIs, internal processes; Track and measure specific CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP Principles and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Field Access, and Payer), Brand Marketing, Training, Market Access, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has high exposure to ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… more
- Merck & Co. (Rahway, NJ)
- …new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development. Are you ready to realize your potential? The Position To support the Director of US Tax Operations in leading and managing tax operations, tax ... compliance , tax risk and indirect taxes for Novo Nordisk...and developing self, team and organization. Relationships Reports to Director of US Tax Operations. Member of NNI Finance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Merck & Co. (Rahway, NJ)
- …The FLEx Co-Lead role is based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply in our Research ... of the performance management processes that govern operations, including tier, clinical siting and compliance councils. Key performance indicators range… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , GMA Oncology, Scientific Engagement is responsible for the ... or Hematology therapeutic area (TA), under the guidance of the Director , GMA Oncology Scientific Engagement ResponsibilitiesExecution of Global Key External Experts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Merck & Co. (Rahway, NJ)
- …effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a subject matter expert in CDISC Controlled ... Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries...reference data to data collection and transformation specifications in compliance with Health Authority regulations and guidance and company… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of research and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager will support CMR's ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Health Canada), and escalating quality concerns. Relationships This position reports to the Associate Director of GXP Oversight and/or Head of GXP Support. ... stakeholders, striving for simplicity, making quality a proactive consideration, ensuring compliance with relevant Good x (eg clinical , distribution,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance with internal SOPs and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager… more
- Novo Nordisk Inc. (Boulder, CO)
- …quality, cost & timely completion of all validation deliverables. Relationships Associate Director . Essential Functions Perform, review & approve ... Plan, manage & perform validation activities at the Boulder Pilot and Clinical GMP Plants. Handle simple to moderate complexity validation projects. Support… more
- GRAIL (Durham, NC)
- …pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director will work cross-functionally to manage Grail's Clinical Quality ... study teams to ensure compliance . **Responsibilities** + Provide day to day clinical compliance support for one or more studies to ensure compliance of … more
