- Aequor (Thousand Oaks, CA)
- …within the remit of role and responsibility Knowledge and skills: Knowledge of case management and medical review SOPs and regulatory requirements for ... MSRT product lead and/or therapeutic area lead Execute ICSR case escalation to GSO as appropriate Execute appropriate ...case escalation to GSO as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and device safety reporting regulations. Relationships Reports to Patient Safety Management . Daily internal interactions with personnel from Patient Safety, Medical ... products Identification of adverse events and event seriousness, causality and case classification (solicited vs. spontaneous, device vs. drug) Perform triage and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support to each product safety team in critical areas such as individual case medical review, risk management , aggregate safety reports, and translational ... other regions. May directly manage complex safety issues related to individual case review, risk management , translational medical safety, and aggregate safety… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionValue Chain Management (VCM) is the accountable organization for our company's Manufacturing Division product supply chain strategy in alignment with ... and launch strategy, long-range demand vs capacity planning, integrated risk management , cost of goods projections, and post-approval product/ process/ supply chain… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …(media relations, groundbreaking ceremonies, milestone celebrations, crisis communications, issues management & other engagements with VIP stakeholders & officials) ... communications function, to include staff/vendor/contractor selection, coaching/developing team, performance management , setting expectations, process confirmation Manage area budget to… more
- Novo Nordisk Inc. (Durham, NC)
- …inspection ready Responsible for supervising their team to include performance management , coaching, development, engagement, and annual merit review. Ensure that ... 10% of the time. (% can change on a case -by- case basis based on the role.) Development...direct supervisory experience preferred Strong working knowledge of database management systems preferred Expert in the area of chemical… more
- Merck & Co. (Hanover Township, PA)
- …milk as well as assist the customer and their staff on the change management journey related to the implementation of our products. Our data-driven solutions are ... manage hundreds of millions of animals worldwide. By putting intelligent, actionable management information into farmers' hands, our solutions empower them to act in… more
- Merck & Co. (North Wales, PA)
- …partners, designs studies, authors study protocols, develops measurement questionnaires, case report forms, data analysis plans, final study reports, scientific ... presentations, and publicationsResponsible for study-related contracting, budgets, and vendor/partner management , and to ensure study conduct is aligned with company… more
- Merck & Co. (Upper Gwynedd, PA)
- …develops value evidence strategies for cross tumor activities. Obtains senior management approval of evidence generation plans. Provides outcomes research leadership ... partners, designs studies, authors study protocols, develops measurement questionnaires, case report forms, data analysis plans, final study reports, scientific… more
- Novo Nordisk Inc. (Boulder, CO)
- …events and non-conformance Drive improvements to operation & maintenance Overall management of all facility services, includes both hard and soft services ... and creating GMP documentation and processes preferred Knowledgeable in the management of utilities systems in a GMP regulated environment required Demonstrated… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Committee and Pre-PC for aligned accounts and leads review of business case and financial impact scenarios. Ensures appropriate stakeholder alignment around business ... to customers o Provides regular updates for Brand Teams and Senior Management on contract performance issues, including over- and under-performing contracts o… more
- Merck & Co. (Rahway, NJ)
- …and data management tasks (eg, User Acceptance Test of electronic Case Report Forms)Monitor clinical studies under the leadership of other Scientists. Develops ... Company's policies and procedures - Plan and coordinate the monitoring and data management activities of each study.Ensure that the study is conducted according to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …necessary for shared services between R&D and Medical affairs, particularly in case when issues impact Medical Affairs programs. Ensure requirements are in place ... products from a quality perspective. Provide regular updates to management on Mid Term strategy (MTS) for MA QA...improvements to stakeholders via the QMS framework (ie, Quality Management Review, Quality Review Board) across the global medical… more
- Novo Nordisk Inc. (Denver, CO)
- …access and drive business impact by collaborating around the clinical management of patients and offering NNI-approved solutions Demonstrates professionalism and a ... ability to communicate technical and scientific product and disease management information This position is part of a job...The Company may however extend this time-period, in which case the posting will remain available on our careers… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) ... timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs… more
- Novo Nordisk Inc. (Denver, CO)
- …productively and respectably challenge and influence target physicians' approach to patient management and adds value by sharing new information and unique insights ... with target physicians Recognizes opportunities to productively challenge HCPs clinical management of patients that respects their knowledge and experience and adds… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of medical accountability and oversight for one or more clinical trialsMatrix management responsibilities across the internal and external networkManages Phase 1 - ... assessment from a physician's perspectiveMay provide clinical input into the eCRF ( Case Report Form) design, participate in the UAT (User Acceptance Testing) and… more
- Novo Nordisk Inc. (Boulder, CO)
- …with Chemical Development, Analytical Manufacturing, Engineering, Facilities, EH&S, Program Management and Quality Assurance. The Technical Team Lead, API ... 15th, 2025. The Company may however extend this time-period, in which case the posting will remain available on our careers website at… more
- Merck & Co. (North Wales, PA)
- …skills as demonstrated through experience in strategy &-marketing business case communication, sales interface, direct customer engagement and/or sales ... launch or launch planning experienceUnderstanding of US market-Strong project management skills as demonstrated by prioritizing activities, using resources… more
- Collins Aerospace (Largo, FL)
- …mapping, strategy, Operations performance & standards, and cost improvement project management .The successful candidate will have sound business and financial acumen ... and Industry 4.0 solutions) and leads implementation of the solutionsEngages factory management to align IE work to customer's business goalsCoordinates and mentors… more
