- Insmed Incorporated (Bridgewater, NJ)
- …Support Program and the reason we are seeking top talent for the role of Director, Case Management. Patients are the core of what we do here at Insmed, and we are ... we want to hear from you! As Director of Case Management, you will be a key member of...customer experience across program stakeholders, host regularly scheduled business review meetings Implement, in collaboration with Marketing, Market Access,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance with SDEA requirements. Relationships This position reports to the Director, Case Review & Compliance Reporting within Patient Safety. This position ... vendor related activities in Patient Safety including, but not limited to, contract review and vendor management support in regards to safety reporting. To serves as… more
- Merck & Co. (North Wales, PA)
- …Tabulation study data deliverables using Extensible Markup Language (XML), Study Data Reviewer Guide (SDRG), Annotated Case Report Form (aCRF)), collaborating ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Medical Consult and Review Physician (MCRP) previously called Global Medical Information Physician (GMIP) for Oncology provides clinical expertise ... a member of several cross-functional teams, including the Promotional Review Team (PRT), and the US and Global Medical...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Millsboro, DE)
- …training and oversight of the animal care staff, serving as a designated reviewer and voting member of the Institutional Animal Care and Use Committee (IACUC), ... such as Reliance, Atlas SRM, WorkDay, myLearning, eTime, Inspire.Compose, review , edit institutional SOPs.Serve as the hiring manager and...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (North Wales, PA)
- …to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and ... objectives.Serve as the liaison and manages correspondence with FDA's promotional review divisions Office of Promotion and Advertising Review (OPDP)/Advertising… more
- Merck & Co. (North Wales, PA)
- …core functions of the GMI group: Medical Information (MI), Medical/Scientific Review of promotional materials and scientific content, Compendia and Pathways ... Information Requests (MIRs).Drives the GMI Team's approach to scientific/medical review of US/Global promotional materials and scientific content and provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date ... of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by… more
- Merck & Co. (Rahway, NJ)
- …but are not limited to: 1. Develops detailed project plans for the collection, review , and cleaning of all clinical data for assigned trials within a specific drug ... vaccine program.- Data includes, but is not limited to, case report form (CRF) data, lab data, other external...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Durham, NC)
- …formulation vessel, lyophilizers, etc.).Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical documents ... meet schedule milestones.Provide QA shop floor support on batch review , alarm response, incursion response and deviation management.Provide QA...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Miami, FL)
- …at product workshops and conferences, as well as consistent and ongoing review of Company promotional materials. Providing Company management with updates on ... workshops and conferences, as well as consistent and ongoing review of Company promotional materials. Regularly monitoring their business...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Insmed Incorporated (Bridgewater, NJ)
- …from regulatory authority or EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.Production of ... eg MACE, Potential events related to metabolite, Liver enzymes. Review of mortality cases, evaluation of CIOMS, production of...with PIs in each reported SUSAR to understand the case assessment. Production of initial narrative to understand each… more
- Merck & Co. (North Wales, PA)
- …and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval for all submissions and associated documentation. ... and approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label Evaluation… more
- Merck & Co. (Rahway, NJ)
- …tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in ... as our company when needed.Responsible to design, create, validate, review , approve and maintain data management tool specifications, including...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Eisai, Inc (Nutley, NJ)
- …partners to meet assigned timeframes and to assure consistency of case records and documentation.Responsible for evaluating, tracking, documenting and processing ... adverse event reports received for assigned product, including the timely review and distribution to co-marketing partners and Eisai affiliate offices.Evaluates the… more
- Merck & Co. (Rahway, NJ)
- …NJ.-Responsibilities will include, but not limited to:Responsible for preparation and review of US international tax compliance forms and disclosures (Forms 5471, ... external stakeholders for Pillar 2 readiness,Assist with ASC 740 review ,Responsible for country-by-country reporting and filing of Form 8975...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of regulatory submissions. Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) annotation and SDTM dataset, ... guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis...identify data inconsistencies and support data review , review analysis dataset specifications and ensure… more
- Novo Nordisk Inc. (Boulder, CO)
- …world-wide prosecution of both platform and composition of matter patent families Review outside counsel work to ensure the work, methodology, and strategy meet ... foreign patent law and practice including patent trends and case law developments to devise patent strategies and advice....The Company may however extend this time-period, in which case the posting will remain available on our careers… more
- Tris Pharma (Monmouth Junction, NJ)
- …and interpret scientific and medical data, evaluate clinical outcome measures, data review and support all appropriate manner of clinical trial activities. The ... or leads various aspects of preclinical or clinical data review including, but not limited to: adverse events, efficacy...statistical analysis plans and data displays; provides input to Case Report Form (CRF) design and data management processes;… more
- Merck & Co. (Rahway, NJ)
- …and pediatric related diseases - a forward/creative mindset. Manage the promotional review process for appropriate materials in support of the pediatric and ... pneumococcal vaccines portfolio.Understand and effectively navigate product review team process - sharing insights and counsel on...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
