- Merck & Co. (San Diego, CA)
- …generate novel CDx models that can be deployed in clinical trials. You will also support preparation of regulatory documents in support of clinical trials.- ... features derived from fit for purpose proprietary data assets to support rapid generation of AI/ML models.Communicate complex AI/ML strategies and insights… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …raw material release and stability studies as needed, generate, and review technical documents that support raw material and product release and stability, will ... the US Food and Drug Administration.Job Responsibilities:Draft and review technical documents supporting raw material and/or drug product release and stability with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …raw material release and stability studies as needed, generate, and review technical documents that support raw material and product release and stability under ... leadership as neededPerform calibrations and calibration verificationsCompile data to support trending analysisWrite, review, and update standard operating procedures… more
- Merck & Co. (Durham, NC)
- …technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents ) to support project and future operations.Identifies and addresses ... your career.Responsibilities may include but are not limited to: Project Support Supports project team as operations expert through start-up, commissioning,… more
- Lundbeck (Bothell, WA)
- …department meetings; draft SOPs, development reports, and regulatory submission documents Provide cross-functional support to upstream/downstream process ... opportunity to gain hands-on experience in analytical development to support drug development from early to late-stage clinical programs.ESSENTIAL FUNCTIONS:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …recommendations for and review of data outputs for collection of specific data, and support the authoring of documents for filings or responding to health ... role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires… more
- Genmab (Plainsboro, NJ)
- …will be responsible for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for ... the Labeling Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, ... of a team of GLLs, manage, develop prepare and implement regulatory documents (eg, draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC,… more
- Merck & Co. (Rahway, NJ)
- …creation and maintenance of the global and country specific dossiers.Providing education and support related to regulatory documents and binders in the Veeva ... Submissions Platform, as needed, to foster consistency.-Developing metrics to track progress and provide updates to management routinely.Other tasks/projects as requested by management.Education: Bachelor's degree in a scientific or regulatory field… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …distribution license applications and renewals and acting as lead paralegal support and coordinator of legal matters, under attorney supervision, on ... is also responsible for providing general and varied legal support to department attorneys, and other individuals within the...including but not limited to independent preparation of legal documents which may include AOPs and AOIs, completion of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/ IRBsMay provide medical ... the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Insmed Incorporated (San Diego, CA)
- …the protocol(s) and program Provide protocol level scientific review of information to support the development and updates for regulatory documents (ie, IND ... Best Medium Workplaces™ lists.OverviewThe Senior Clinical Research Scientist (CRS) will support and work predominately with the Clinical Trial/Indication Lead(s) and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organized, proactive, and professional Executive Administrative Assistant to provide comprehensive support to leaders and members of GMP Quality Assurance team and ... supportCommunicationOffice and Project ManagementContract processing, Agreements, and Payment ManagementProblem-solvingRESPONSIBILITIESAdministrative support : Manage and maintain executive calendars, including scheduling meetings,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team ... all communications via contact reports.Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in… more
- Merck & Co. (North Wales, PA)
- …science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.The Medical Consult and Review ... in promotional materials, external communications and Field Based Employee training content.- Support Country Medical directors, as HQ point of contact and Subject… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, ... of a team of GLLs, manage, develop prepare and implement regulatory documents (eg, draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against ... attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and vendors as appropriate.- Provide clinical administrative … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that ... prepare FDA submissions, including but not limited to briefing documents , breakthrough therapy designation requests, orphan drug applications.Participate in global… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …providing quality oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This ... manufacturing to troubleshoot issues.Key Responsibilities Read, interpret and revise documents such as SOPs, work instructions.Develop positive relationship with the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are ... through creation of briefing materials and meeting preparation Lead and/or support global filing activities for submissions Present regulatory strategies including… more
