- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include ... patient support programs data strategy aligns with organizational goals and regulatory requirements, working closely with key stakeholders to drive impactful change… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …CMR functions within the role-based training processes (ie automation, technology, process optimization). Relationships Reports to Director or above within ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …awareness of best practices for reproducible data science, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)- Ensure ... AI/ML deliverables- Contribute, with limited supervision, to documents submitted to regulatory or pricing authorities- Proactively identifies and manages risks in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liasions to ensure sucessful implementation of CDx and data ... collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... timelines for the assigned projects. The individual will also contribute to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... including Risk Management PlansEfficiency of Process , SOP: Leads the process and provides guidance. Proactively ensures regulatory and good… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and PPQ as needed. Conduct data review and analysis, data-driven decision-making process , and support data transfer to the appropriate data repository - liaison ... Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …such actions. Participate in cross-functional teams responsible for regional and global process improvements in the operational efficiency of PJ Lead and Tech Unit.- ... 4 or More Years Extensive experience in project management, process , product, and/or analytical development activities and pharmaceutical/oncology project… 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 Nordisk is one...and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has experience working on Phase I-IV study ... and/or pharmaceutical industry across multiple therapeutic areas and experience with regulatory submissions and inspections. Finally, this position has strong skills… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affiliate, and/or in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality. Regularly interfaces with multiple NN ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...by sales force Develops and maintains reporting and evaluation process for sales representative refrigerator thermometers including replacement and… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Project Management and Strategic ... the "Apply" button, I understand that my employment application process with Takeda will commence and that the information... Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project… more
