- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational ... during the vendor selection process.Ensures appropriate oversight from a clinical trial risk and compliance standpoint and...oversight from a clinical trial risk and compliance standpoint and establishes a comprehensive interface for risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Action (CAPA) plan and related effectiveness measures.Ensures appropriate oversight from a clinical trial risk and compliance standpoint and establishes a ... in due diligence activities during the vendor selection process.Close partnership with clinical quality management, SVO and other compliance functions within and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Insmed Incorporated (San Diego, CA)
- … operations including study planning, financial oversight, project deadlines and ensuring compliance with Good Clinical Practices as well as federal and ... Clinical Sub-team meetings.Approves action plans to address protocol compliance , safety, data and administrative issues with investigational sites and CROs.Job… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This ... the successful delivery of study diversity plans in adherence with Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; ... Represents clinical function at meetings with health authorities; Oversees management...listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develops biomarker strategy… more
- Buckeye Community Health Plan (Obetz, OH)
- …more efficient and streamlined workflow. Bachelor's degree in Nursing, related clinical degree or equivalent experience. 7+ years of quality management, quality ... Formulate and establish policies, operating procedures, and goals in compliance with internal and external guidelines License/Certificates: Certain states may… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to ... security, regulatory, and compliance standards. Collaborating with business and EIT stakeholders, you promote awareness of best practices and strengthen … more
- Carondelet St. Josephs Hospital (South Tucson, AZ)
- …at a time. Let your career find its purpose here at Carondelet. Director Supply Chain Position Summary Directs an organization's overall supply chain operations for ... including the evaluation of spend to established targets, including contract compliance , budget, forecast etc. Develops strategic plans to improve productivity,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Chemical Biotechnologies Description:The Director of Chemical Biotechnologies reports to the Senior Director Chemical Biotechnologies in ... of work that includes direct project support of the current our Company clinical pipeline and prospective technology development that enhances our ability to deliver… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …hires during on-boarding and provide on-going support, as determined by Field Director Ensure personal compliance with all internal/external SOPs/rules and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life ... and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation of… 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 ... manage cross-functional study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met according to… more
- Tris Pharma (Monmouth Junction, NJ)
- …program development (ie, substance use disorders, ADHD, etc.); Designs and implements clinical trials ensuring compliance with regulatory standards and industry ... the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. The Executive/Senior Medical Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of scientific summaries, abstracts and manuscripts Provide leadership in the execution of clinical trials Ensure compliance with SOPs, ICH, GCP and other ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...new medicines for patients. The Position As Senior Medical Director for the liver disease team, you will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team ... authorship agreements, financial disclosures and author approvalsEnsures documentation of compliance with authorship and publication guidelines as stipulated by the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Associate Director , Strategic Content Development, Global Medical Affairs - Alzheimer's Disease, in the ... to the AD portfolio and continued support as a key partner to Clinical Development, Real World Evidence and Commercial Operations.The incumbent will provide disease… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior ... Director , GMA Oncology (Global Medical Affairs team lead for...drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support… more
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