- 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 ... diligence activities during the vendor selection process.Ensures appropriate oversight from a clinical trial risk and compliance standpoint and establishes a… 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, ... components for designed eCRFs, programmed Edit Checks, Reporting Library, etc.Develop training strategy for companywide adoption of Clinical Data Standards,… 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 ... study documents eg informed consent forms, study guidelines, operations manuals, training materials.Leads Clinical Sub-team meetings.Approves action plans to… 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
- 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 ... training programs and conduct Segregation of Duties reviews.Regulatory Compliance Activities:Collaborate with legal and compliance representatives 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)
- …from an accredited institution with current medical licensure in the US and appropriate clinical training and minimum 12 years experience in a clinical ... program development (ie, substance use disorders, ADHD, etc.); Designs and implements clinical trials ensuring compliance with regulatory standards and industry… 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
- Merck & Co. (Rahway, NJ)
- … supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development, and seamless ... to lead and support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …response documents, (non-) promotional materials, educational slide deck and other internal training resources, within legal and compliance regulations. Provide ... areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …training processes (ie automation, technology, process optimization). Relationships Reports to Director or above within CMR Training & Knowledge Management. ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...CMR training strategy Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP… 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 ... for ensuring that they and their team act in complete and total compliance with all laws, regulations and policies. Responsible for administrative and management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents, (non-) promotional materials, educational slide decks, and other internal training resources, within legal and compliance regulations. Provides ... research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the… more
- A-Line Staffing Solutions (Moab, UT)
- …direction, staff development, financial management, quality improvement initiatives, regulatory compliance training , and advocating for nurses. If interested, ... No Temp or Contract work involved Reports to: Chief Clinical Officer (CCO) Anticipated schedule: 40+ hours/week, shifts can...with the Trauma Medical Director and Program Director to ensure quality care and compliance … more
- Volunteers of America Mid-States (Louisville, KY)
- …Program- Leadership Development Program VOA University - Staff Development VOA Academy - Clinical Training and Development JOB SUMMARY AND QUALIFICATIONS: We are ... POSITION TITLE: Senior Director of Fund Development LOCATION: Louisville, KY STATUS:...utilizing data to inform fundraising strategies and decision-making. 9. Compliance : Ensure compliance with all relevant fundraising… more
- Careerbuilder-US (Brooklyn, NY)
- Job Title : Associate Director of Nursing Location: Brooklyn, NY 11213 | Travel & Local Contract Contract: 3+ months (Possibility Extension) Pay Range: $70 - $80. On ... W2 Note# Recent 2 years hospital experience required as an Associate Director of Nursing. Position Summary: Off shift weekend/holiday Supervisors. Assumes shift… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Provides oversight of activities performed by ... writing of global standard operating procedures; Monitors and enforces compliance of standard procedures and processes.People Management: Has administrative… more
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