- Genmab (Yardville, NJ)
- …best, and authentic is essential to fulfilling our purpose. Associate Digital Product Manager , Global Drug Safety and Pharmacovigilance This person will be based ... 8+ years of experience as a product owner, product manager , senior business analyst in Global Drug...it back to the business stakeholders. Solid understanding of regulatory guidelines and data standards is a… more
- Genmab (Mercerville, NJ)
- …Senior Contract Manager specializing in nonclinical and clinical lab and data services to join our team in Research & Innovation Outsourcing Management. The ... Senior Contract Manager will be responsible for overseeing the contractual aspects...execution of contracts for nonclinical and clinical lab and data services, including master services agreements, work orders, consultancy… more
- Genmab (Mercerville, NJ)
- …with business and functional teams. As security leader you are part of a global information security team with main focus on stakeholders located in the Genmab US ... stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US Market and Commercial Teams (and...Information Security will report directly to the VP and Global Head of Information Security and Risk & Compliance,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, ... 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)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Biostatistics and Data Management team and performs programming tasks, including SDTM… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...the good day-to-day management of data at Daiichi Sankyo including: the stewardship organization, … 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 ... trial data .Ensure company clinical trial data on the Vivli data sharing and research portal is current.Lead/co-lead global process development and… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify potential safety signals, tracks safety signals in ... the global electronic signal tracking tool and performs safety analysis/evaluation....Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... 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 ... well as marketing mix align with the Brands' goals and objectives.- Regulatory approvals: Responsible for PMRT (Product Material Review Team) PGC (Promotional Grant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred. Preferred1 or more years of experience in a leadership role within Data Science in a Global Life Sciences organizationDemonstrated experience in the ... for cardiovascular diseases, 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)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... 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
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …SPARC GRA/ GRO is responsible.Must understand and be updated with current Global Regulatory filing requirements and eCTD structure.Collaborate with Strategists ... reports to upper management.Validate and QC of incoming and outgoing regulatory data /documents.Archival of other necessary submissions and/or documents.Review… more
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development and life cycle management. Represents the function in global regulatory /heath authorities' meetings. High-level negotiation and oversight of ... 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)
- …collaborates closely with data manager to ensure high quality data . Work closely with internal statistical programmer.- Global strategy to Improve Drug ... 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
