- 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
- Merck & Co. (Rahway, NJ)
- …Management within the Global Data Management & Standards (GDMS) organization, the Manager Global Data Standards - Ops and Reference Data ... Job DescriptionPosition Description: Manager , Operations and Reference Data Management, Global Clinical Data Standards Working closely with the Global… more
- Aequor (Newbury Park, CA)
- …process explore avenues to simplify and streamline. Provide operational support for Regulatory Data Management, Submissions, and EU CTR. Develop and implement ... This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works...Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base.… more
- Arthrex (Naples, FL)
- …and medical education in orthopedics. Arthrex is actively searching for a Sr. Project Manager , Program Manager - Regulatory Affairs who is responsible for ... Patients Better (TM) .Essential Duties and Responsibilities: Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs.… 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)
- …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)
- … 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 other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programming is a member of the Biostatistics and Data ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may… 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)
- …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)
- …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
- Aequor (NJ)
- …/ Strong knowledge of the global drug development process and global regulatory requirements. Proficient and strong analytical skills. Strong communication ... 100 % remote Manager prefers local candidates (will consider non local...and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …completeness of data collection programs and associated SDEAs in the Global Safety PV Oversight System Monitors and manages the Patient Safety Contracts ... and clinical trials complaint handling Ensures local/affiliate SDEA templates meet both Global and local regulatory requirements Supports audit and inspection… more
- Catalent (St. Petersburg, FL)
- …continuous improvement and inspection readiness. Assess changes to GxP systems and data integrity regulatory requirements and communicate requirements to site ... to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support… 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
- 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
- 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
- Fidelity TalentSource LLC (Merrimack, NH)
- …Skills You Bring 3 years of financial services experience with an asset manager or custodian bank, preferably in mutual fund operations with exposure to Corporate ... and escalate appropriately. The ability to cleanse corporate action data received through custodian banks, agents, and brokers. You...excess of $1 billion at a given time. The Global Middle Office acts as a servicing center for… more
