- 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
- Eisai, Inc (Nutley, NJ)
- …obtained or related to adverse event reports, cumulative reports, or international regulatory reports and requests. 20%Set standards for data collection and ... and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with operating agreements with… more
- Eisai, Inc (Nutley, NJ)
- …2 years of work experience in Pharma in job offered or as Product Manager / Global Delivery Lead. Also requires 2 years of leadership experience with/using the ... following (which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting Regulatory processes… 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
- Merck & Co. (Rahway, NJ)
- …the "Business") in areas such as Privacy and Policy Management . The Technical Product Manager is a key member of the Legal, Compliance and Security Value team. - ... The Technical Product Manager plays a critical role in implementing, managing, and...- Ensures compliance applications and platforms adhere to relevant regulatory and industry standards, collaborating with stakeholders to identify… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor ... equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end… 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 ... for supports of strategic leadership to manage DSI QA Functional activities and Global QA activities. This position performs support tasks Head Global R&D… 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 ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data , CMC,… 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)
- …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 ... strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units. Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as a ... services they provide to support drug development processes and global submissions. This position provides expertise within Data...team as an extended part of committee. Advise Study Data Manager on complex vendor management issues… 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/evaluationMay...Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, ... and on-site monitoring & oversight activities using various tools to ensure:o Data generated at site are complete, accurate and unbiasedo Subjects' right, safety… more
- Merck & Co. (Rahway, NJ)
- …and CRD (Clinical Research Director) as needed.Works in partnership with GCTO ( Global Clinical Trial Operations) country operations, finance, regulatory affairs, ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager throughout all phases of… 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
- Lundbeck (Queens, NY)
- …be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative ... lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand… 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
- Lundbeck (Bronx, NY)
- …be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative ... us on our journey of growth!As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio...Leadership - Ability to use digital tools and apply data -based insights to create opportunities, develop strategy & tactics,… 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
- Merck & Co. (Rahway, NJ)
- Job Description Responsibilities As a Design Control and Risk Management Data Manager , you are a key member of the Device - Development Team. Your will main ... and relationships.- Manage open deliverables and tasks. Manage the Global Design File from concept, launch and post market.--...and post market.-- Support second person review with source data for regulatory filing. Support Design Transfer… more
