- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global ... other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM)… more
- Merck & Co. (Rahway, NJ)
- …the intellectually curious, join us-and start making your impact today. -Overview: Global Project and Alliance Management (GPAM) sits in the research & development ... tactical input from diverse disciplines (eg, biology, chemistry, pharmacology, clinical, regulatory , access, supply, and other areas), as applicable to the project.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions to ensure SMTs are performing according to necessary ICH/GCP-relevant regulatory requirements and global , departmental and geographical SOPs, policies ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...related to US/Ex-US regulatory submissions. In addition, this individual will be responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Aequor (Bothell, WA)
- …relationships. Demonstrated ability to work effectively with US FDA, EU and other regulatory agencies. Substantial knowledge of QSR, GMP, FDA, GAMP, ICH, ISO and ... and associated worldwide regulations. Ensure site meets the expectations of the Global Client Data Integrity program, including but not limited to the annual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes ... a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business expectations to execute … 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
- Aequor (Thousand Oaks, CA)
- …for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and ... contracting negotiations and execution. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the sourcing processes… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionAbout Insmed Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. ... a difference while having fun? Yes? Then maybe you will be our next Manager of US Compliance! This role will implement day-to-day support across the US Compliance… more
- Merck & Co. (Durham, NC)
- …the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering ... shop floor leadership.-Key Responsibilities for a Drug Product Operations Manager Accountability - Project SupportFirst-line operations supervisor with a team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as building a network with key staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and company trade ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject… more
- Merck & Co. (Irving, TX)
- …and adverse reports in accordance with internal, FDA, CFIA and USDA regulatory policies.- The position will require developing trial protocols, monitoring and ... within the research world.Communicate between various Internal departments such as Global , R&D, business development and marketing to improve innovation pipeline,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for at least two global development projects that have been submitted to regulatory agencies preferred Travel Ability to travel up to 10% Daiichi Sankyo, Inc. is ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Legend Biotech USA, Inc. (NC)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
