- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a culture of compliance at all levels.Create and maintain project management methodologies. Support the global GMP quality annual objectives, strategic ... collaboration with Global External Supplier QA teams.Collaborate with Global Quality Management System (QMS) teams on regulatory-related...to recommend metrics and report the state of GMP Quality and compliance of Daiichi Sankyo and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Associate Director will also be responsible for the creation, management , and documentation of GCO's CRO SOP review and maintaining the master Daiichi ... areas (eg clinical research & development, clinical science, clinical quality assurance, project management ) preferredStrong leadership, collaboration,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Medical Director responsible for Communication Strategy and Medical Program Management on tracking and management of budget.Support Head of Publications- ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as the principal functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP ... relevant advancements to optimize system performance and functionality.- Data Quality , Testing and Release ManagementEstablish and enforce robust data governance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and issue management with strategic development partners.Close partnership with clinical quality management and other compliance functions within and ... centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk...risks.Manage and oversee the CTOR team who support GCO Quality by Design, risk and issue management .… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …initiates writing of global standard operating procedures; Monitors and enforces compliance of standard procedures and processes.People Management : Has ... portfolio or specific therapeutic areas from Phase 1 through life cycle management . Provides oversight of statistical activities performed by direct reports or staff… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, maintenance, ... Liquid tumors, understanding of the CDISC (SDTM, ODM.XML, CDASH) industry standards, Metadata management and Data Mappings and are some of the key requirements of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of excellence to identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of success ... on-site visits to monitor study sites protocol execution and compliance to applicable DS SOPS and procedures -Enable ways...SOPS and procedures -Enable ways for GPTs and Study Management Teams to have conscious inclusion trainings, and tools… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with clinical and medical teams, CROs and other vendors to ensure high quality of coding deliverables to support drug development processes and global submissions. ... This position provides leadership within Data Management by partnering with internal and external stakeholders to optimize medical coding processes, technology, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... programming processes supporting global submission. Responsibilities - Statistical Programming Management : Coordinates outsourced statistical programming of analysis data sets… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... SAS and R. The position will require proven skills in continuous improvement, project management , change management , and risk management . The position will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior ... studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... harmonization of programming processes supporting global submission.Responsibilities- Statistical Programming Management : Coordinates outsourced statistical programming of analysis data sets… more
- Merck & Co. (Rahway, NJ)
- … management duties.Through their leadership and strategic guidance, the Director will ensure that their interdependent and multidisciplinary team develops and ... team activities are completed with the highest regard for safety, quality and regulatory compliance .Qualifications:Education Minimum Requirement: This position… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe US CA Veterinary Insights and Medical Affairs Director sets the strategic vision for the development, refinement, and implementation of veterinary ... of healthier animals in a highly competitive market.Reporting to the Executive Director , US CABU Professional Services, this position works closely with Marketing… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …manufacturing environment. Experience supporting compliance investigations and change management . Experience working with Quality systems. Experience working ... to lead and support facility operations, process development activities, compliance investigations/change management , authoring of GMP documentation, and… more
