- Merck & Co. (Rahway, NJ)
- …and plan for the assigned group -of projects/products.Effectively communicates CMC regulatory strategy, risk , mitigation, and overall plan to the GRACS, ... molecules to peptides, pediatric formulations, and devices. The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety:… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... projects in Late Development Statistics.Lead the interaction with Clinical, Regulatory , Statistical Programming, Data Management, and our company's Research… more
- Merck & Co. (Rahway, NJ)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Clinical Director ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary...execution of clinical studies. Work closely with a cross-functional group of experts in commercialization, regulatory affairs,… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May ... Scientists in the execution of clinical studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... of patients and global human health. Responsibilities :Supervises a group of statisticians in Late Development Statistics.Provides biostatistical and operational… more
- Merck & Co. (Rahway, NJ)
- …authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings-Overseeing a group of scientists (in a scientific and/or ... Job DescriptionSenior Directors in the Pharmacometrics group within the department of Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative… more
- Merck & Co. (Rahway, NJ)
- …process strategies. Acts as a technical resource to other members of the group . Plans appropriately to ensure adherence to timelines. Interface with members of study ... Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings. Participates in… more
- Catalent (Harman, WV)
- …systems, including investigation/deviation management, CAPA tracking, change control, risk management, supplier quality, audits and inspections, raw materials ... release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality system functions, as needed. The Role Provides… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... all applicable environmental, health and safety regulations. Relationships Reports to Senior Specialist EHS at US headquarters in MA. Internal relationships include… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Description Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies ... of promising new medicines to help people. Under the Group 's 2025 Vision to become a "Global Pharma Innovator...QA. Within assigned GPTs, facilitate the implementation of a risk -based quality management process fully embedded through trial design,… more
- Merck & Co. (Rahway, NJ)
- …Scientists in the execution of clinical studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Merck & Co. (Washington, DC)
- …for the business, leading engagement legislative processes, partnering on regulatory engagement and working with stakeholders via direct relationships, coalitions, ... grassroots advocacy strategy to contribute to federal legislative and regulatory priorities.Develop collaborative relationships with stakeholders including trade associations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Description Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies ... of promising new medicines to help people. Under the Group 's 2025 Vision to become a "Global Pharma Innovator...budget, timeline, achievement of defined milestones and overall project risk management. He/she will assess project issues and develop… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Description Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies ... and a robust pipeline of promising new medicines to help people. Under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in… more
- Merck & Co. (Rahway, NJ)
- …at its Kenilworth, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director ... leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates.--An established… more
- Merck & Co. (Boston, MA)
- …drug development, leadership, recruitment capabilities, management skills to direct a group of individuals, and excellent communication and collaboration skills to ... CTD submissions and NDAs.Regular updates with key cross-functional partners (Discovery/Late-Stage/ Regulatory ), as well as other disciplines.Establish novel endpoints for… more
- Discover Financial Services (Riverwoods, IL)
- …cloud, and automated testing.Hire, retain and lead high-functioning, diverse group of engineering professionals, establishing clear objectives and key results, ... consistent, thoughtful and customer-centric technology experts. This includes ensuring the group is adhering to principles of engineering excellence within their… more
- Citigroup (New York, NY)
- …excellent organizational, follow-up and time management skills **Job Family Group :** Risk Management **Job Family:** Regulatory Risk **Time Type:** Full ... solutions, communicating project results, and obtaining buy-in for change **Team Overview:** The Risk Regulatory Engagement team ensures the Independent Risk … more
- Citigroup (New York, NY)
- Citibank, NA seeks a Regulatory Risk Group Manager for its New York, New York location. Duties: Conduct internal and external research on bank management of ... experience must include: Integrating strategy driven requirements into existing risk management processes and governance; and Senior ...Range: $184,343.50 to $255,000 Job Family Group : Risk Management Job Family: Regulatory Risk… more
- BMO Financial Group (Chicago, IL)
- … Risk Program by enabling the Bank to make sense of the fast-moving regulatory landscape on climate risk and translate prudential regulatory signals and ... risk management guidance driving the design and implementation of our climate risk management framework. The Senior Advisor, Climate Risk Guidance will,… more
