- 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 Regulatory Affairs (GRA) Process...Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality rules… more
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, AbbVie Inc., ... regulatory and business needs. . Identify and gather data needed to support filings, responses to inquiries, and...driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL),… more
- Vantage Specialty Chemicals (Fairfield, NJ)
- …SDS's, PCN (poison control notification), and CLP (classification, labeling and packaging), regulatory data sheets. + Monitor, interpret, assess, and develop ... it here. For more information visit: www.vantagegrp.com or LinkedIn/vantage **POSITION SUMMARY** Regulatory Affairs Senior Manager is responsible for leading the… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …working groups, and relevant industry thought leaders + Monitor and analyze global regulatory intelligence sources for the most current changes and ... proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through… more
- Stryker (Allendale, NJ)
- …and ensure ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interacts ... regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. + Participates in advocacy activities of a more… more
- Pfizer (Pearl River, NY)
- …willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires ... guiding the Labeling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary...and procedures. + Demonstrated ability to interpret and apply global and local regulatory guidance around labeling… more
- Deloitte (Morristown, NJ)
- …the opportunity to help clients execute transformational change by aligning their global executive and equity compensation programs with their business and talent ... where you can help drive strategic initiatives across a global business platform, the Global Employer Services...proxy statement studies and analyses of other publicly available data sources + Benchmark, review, and assist in the… 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
- AbbVie (Florham Park, NJ)
- …Call Center staff, and managing the development, approval, and maintenance of global and region-specific medical/technical global content (GC) response documents ... literature and clinical guidelines, and assists in the development/approval of Data on File in accordance with established policies and practice standards.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to support the collection of diverse external data types. + Advises Study Data Manager on complex vendor management issues and provides guidance or feedback ... equal opportunity employer including veterans and people with disabilities. **Summary** The Manager External Data Management, is accountable for an end-to-end… more
- Fiserv (Berkeley Heights, NJ)
- … global scale, come make a difference at Fiserv. **Job Title** Senior Product Manager - Banking Data Products **What does a successful Senior Product ... Manager , Banking Data Products, do at Fiserv?** At Fiserv, we are...+ Participate in sales calls as a SME on data products. + Ensure products adhere to regulatory… 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 ... and immune disorders. **Summary** Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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
- Pfizer (Pearl River, NY)
- …Managers and the larger Study Management delivery of the study. The Study Operations Manager may partner with the Global Study Manager , Study Start ... including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable. The Study Operations Manager...for tasks as designated on the study by the Global Study Manager which may include: +… more
- Deloitte (Morristown, NJ)
- …following topics: trading, operations, lending, core banking platforms, compliance monitoring, regulatory reporting, risk or case management, or data management ... Financial Services Risk Management Manager Our practitioners have the opportunity to engage...Learn how to identify, evaluate, and prioritize business, operational, regulatory , and technology risks as well as risk mitigation… more
- Sanofi Group (Bridgewater, NJ)
- …PV Zone Leads + Regional PV Head + Country Medical/ Regulatory /Quality Teams and Country Manager + QPPV + Global PV Operations Team + Global Medical ... the assigned country are performed in compliance with the Global PV policies, as well as global ,...in-country partner functions, including but not limited to Medical, Regulatory , Quality, Commercial, Legal, and Country Manager .… more
- Sanofi Group (Bridgewater, NJ)
- …the strategic vision, planning and oversight on CHC PV systems and data management solutions, including the Global pharmacovigilance database. Responsibilities ... **CHC PV Data Strategy and Management Head** + _Location: Bridgewater,...PV Affiliates, PV Compliance, Safety Signal & Risk Management, Global Medical, Regulatory , Quality and other business… more
- ConvaTec (Bridgewater, NJ)
- …+ Providing analytical data as needed. + Escalate urgent issues to manager as needed. **Principal Contacts** + Internal - Internal: Global Logistics, ... Service, Supply Chain, Transportation Specialists, Commercial, Tax, Information Management, Global Master Data , Customs, Quality Assurance, Packaging and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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