- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interactions, including leading team through creation of briefing materials and meeting preparation Lead and/or support global filing activities for submissions ... science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions. Support FDA meeting preparation including preparation of ... briefing document, meeting request, response to FDA preliminary comments and logistics. Support FDA meeting preparation including preparation of briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … interactions with Vendors on packaging design and patient kit supply preparation , label generations and approvals. Support regular vendor/sponsor discussions to ... and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.Has sufficient knowledge to identify critical… more
- Eisai, Inc (Nutley, NJ)
- …Management: Assist with creating, updating and maintaining project trackers in EPIC Provides support for document preparation and follow-up ( eg Informed Consent ... from you. Job Summary Job Summary The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up, conduct and close-out)… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …position provides engineering and automation services with front line, on the floor support for the manufacture of our products for our patients. The engineer ... science and risk-based verification requirements and is required to supply support /technical knowledge for the development/refinement and implementation of the GEP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quarterly Business Reviews (QBRs) overview for Investor Relations and OBU to support Earnings Call preparation by liaising with Regional Marketing/Insights teams ... skills, and also have strong background in Oncology.Responsibilities- Business Planning Support : Ensure OBU produces Mid and Long Term Global Forecasts post… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, ... US FDA and EU EMA) for assigned projects with support , on CMC matters. This position supports Health Authority...EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing book, to training and preparing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with internal and external stakeholders & communicate upcoming congress activities in support the of the Regional Marketing group. Must be well-versed in ... to address them.Develop and recommend events that drive key messaging, support strategy, and foster relationship-building opportunities with customers and partners.… more
- Merck & Co. (Upper Gwynedd, PA)
- …activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively ... ensure consistency and seamless progression through the study lifecycle.Inspection Preparation and Management Responsible for maintaining current regulatory inspection… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Draft ROCs for more complex contacts Prepare routine correspondence Provide proactive support and technical assistance during preparation and review of ... strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Figures (TLFs) generated by vendor, ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain ... institutional knowledge across oncology compounds and support building up oncology programming standard on datasets and TFLs to improve efficiency and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serve as the Labeling Project Lead. This position leads labeling meetings for preparation of responses to comments from HAs, meeting required timelines to achieve ... partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and updated Core...development or approval for either the US or EU. Preparation of updated Core Data Sheets, and EU and… more
- Aequor (Newbury Park, CA)
- …standards and local regulatory requirements. To manage and execute of the preparation , delivery and electronic archiving of documentation for inclusion in US ... Affairs Senior Associate position are: Assist US Regulatory Lead to support regional regulatory activities (eg IND submissions and agency meetings) Provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Design documents. Perform system customization and configuration work as needed to support new and existing functionality. Responsible for the development of the ... affect existing functionality. Responsible for production turnover. Resolve production support issues within established service level agreements. Provide project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... pursue a career within the pharmaceutical industry.Therapeutic AreaAssist in preparation of regulatory documents.Work with global stakeholders from headquarters on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of the LCA Budget including but not limited to, annual budget preparation , quarterly adjustments (LE process), tracking of spend, preparation of ... other related tasks, as assigned. In addition, the Specialist will provide support of the overall Corporate Records Management Program, as assigned.- Corporate… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people.This position is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. ... responsibility include but are not limited to activities of: Media Preparation , Fermentation, Tangential Flow Filtration, Process Monitoring, Sampling, and area… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sessions and workshops on best practices and performance improvement strategies Provide logistical support and help in the preparation of meeting materials (PPT ... CTBO Analyst Intern: Assist in providing operational and analytical support to the CTBO team Help in the collection,...in the collection, organization, and analysis of data to support various projects Utilize data to identify trends, patterns,… more
- Aequor (Thousand Oaks, CA)
- …Exposure to GMP and Aseptic technic and benchwork experience. Lab work. Support Microbiology lab with analytical testing. Pipetting water testing, Observing for ... within Quality Control at the Thousand Oaks site and to directly support both manufacturing and Quality Control operations. Under minimal supervision analyze… more
