- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(data management, clinical operation and other functions) to implement clinical development plan : study ideation, protocol development, review case report from ... clinical scientists, formulate an optimal structure and a resourcing plan , and develop capabilities to serve the needs of...budget allocation, and assessment of needs including training, data review tools, etc. Standing PRG reviewer for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from healthcare professionalsOversee the timely execution of the development, review and approval process incorporating input/recommendations from other reviewers ... (eg, Peer Reviewers, Legal Affairs reviewer , Supervisor) and discussing with other functions as needed...discussing with other functions as needed Ensure detailed peer review of medical information documents and provide appropriate and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strategy, comparability plans and data governance initiativesProvide critical input and review for validation master plans, PPQ and comparability protocols and ... reportsServe as reviewer /author of a variety CMC sections or regulatory submissions,...cross-functional organization with multiple partners with competing priorities.Ability to plan , multitask, prioritize and be an effective and influential… more
- Merck & Co. (North Wales, PA)
- …aCRF; knowledge of Analysis Dataset Model (ADaM) and Analysis Data Reviewer 's Guide (ADRG) considered a plus.Excellent communication and interpersonal skills and ... the use of global outsource partner programming staff.Develop and manage project plan using Microsoft Project or similar package.Active in industry forums and… more
- ASAE (Washington, DC)
- …address current and anticipated needs of the pharmacy profession. Develop/ review title, learning objectives, activity descriptions, content (eg, slides, storyboards, ... outlines, and self/post-assessment questions) as the authoring expert and/or as a reviewer in collaboration with subject matter experts (SME). Ensure that all… more
- KENTUCKY SOCIETY OF ASSOCIATION EXECUTIVES INC (Washington, DC)
- …address current and anticipated needs of the pharmacy profession. Develop/ review title, learning objectives, activity descriptions, content (eg, slides, storyboards, ... outlines, and self/post-assessment questions) as the authoring expert and/or as a reviewer in collaboration with subject matter experts (SME). Apply best practices… more
- Tennessee Society of Association Executives (Washington, DC)
- …to address current and anticipated needs of the pharmacy profession.Develop/ review title, learning objectives, activity descriptions, content (eg, slides, ... outlines, and self/post-assessment questions) as the authoring expert and/or as a reviewer in collaboration with subject matter experts (SME). Ensure that all… more
- John Snow, Inc (Boston, MA)
- …on pricing tools and guidance. Work with assigned cost proposal budget reviewer to troubleshoot complex budgeting issues and solicitation requirements and ensure ... review feedback is incorporated into final budgets. Analyze, make...Paid time off Parental leave Professional development assistance Retirement plan Tuition reimbursement Vision insurance Schedule: 8 hour shift… more
- Takeda (Boston, MA)
- …influence in departmental and cross-functional task-forces and initiatives.Lead regulatory reviewer in due diligence for licensing opportunities.Partner with global ... both the regulatory and access environments to strengthen product development plan (s) and adopt regulatory strategies in a timely manner.Responsible for… more
- Takeda Pharmaceutical (Boston, MA)
- …in departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global ... impact both the regulatory and access environments to strengthen product development plan (s) and adopt regulatory strategies in a timely manner. Responsible for… more
- ClickJobs.io (Boston, MA)
- …in departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global ... impact both the regulatory and access environments to strengthen product development plan (s) and adopt regulatory strategies in a timely manner. Responsible for… more
- MedStar Health (Washington, DC)
- …long-term success and sustainable growth for MedStar Family Choice - DC's health plan . The incumbent requires a passionate advocate for health equity, coupled with ... Family Choice - District of Columbia. Responsible for integration of the strategic plan of the organization. Manages the operational and financial results of the… more
- San Francisco Health Plan (San Francisco, CA)
- Join us at San Francisco Health Plan (SFHP). As an HR professional, you can help improve the health outcomes of the SF Communities.Reporting to the Director of Human ... ensure training objectives are met.Partner with HR Operations team on benefit plan education and communication to staff and leadership.Administer SFHP HR policies,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Independent Medical Education (IME) Assist in developing medical education priorities and IME plan in collaboration with IME lead Review and assist with ... and reviews IME grant proposals, represents Medical Affairs in Promotional Review Board (PRB) activities including reviewing medical and scientific content of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to...with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as point… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Acceptance Testing) and CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data Review Plan (IDRP)- Accountable for the ... medications when needed- Addresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as needed- Study-specific… more
- Merck & Co. (Durham, NC)
- …department Adapts plans and priorities based on departmental budget and profit plan to address resource and operational challenges Decisions are guided by policies, ... procedures and business plan ; receives guidance from manager Provides technical guidance to...is trained on new or revised processes or procedures Review and approve Quality Notifications (QNs) - Author, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related integrated evidence generation strategies and activities as part of the USOMA Plan . Provides medical review of expanded access programs (EAP) and, ... Medical Affairs (USOMA). Develops the USOMA strategy and tactical plan as part of the US Brand Strategic ...investigator-initiated studies (IIS) as part of a US IIS Review Committee, for assigned compound. Collaborates with Global Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the assessment ... medications when neededAddresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as neededStudy-specific subject… more
- BrightSpring Health Services (Bethesda, MD)
- …ensure services are provided as indicated in each person's Individual Program Plan (IPP).Coordinate Incident/Accident Review process, monitor for patterns, and ... in the implementation and delivery of the Individual Service Plan (ISP). Supervises the delivery of service and ensures...receive weekly data sheets, and BSPs are monitored.Ensure daily review of IBAMs and triage reports, with follow-up in… more
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