- 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 ... Oversight Manager to oversee all aspects of Good Practice (GxP) documentation management within our organization. This role will be responsible for ensuring that… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Batch Record & Document Coordinator as part of the Technical Operations team based in Raritan, NJ. ... organization and function within a team environmentGather production information to support OOS, Deviation, and CAPA logsReview of specific in-process, and finished… more
- Merck & Co. (North Wales, PA)
- …Assist with congress plan activities including maintenance of presentation trackers, - document trafficking, author travel request management , archival of final ... With guidance and direction from the Director/Associate Director Publication Management , the Sr. Specialist Publication Manager coordinates publication planning and… more
- Insmed Incorporated (NJ)
- …initiatives. This internship provides hands-on experience with enterprise IT support , including troubleshooting, user assistance, asset management , and ... hardware, software, and network issues, escalating to senior staff as needed. Support Active Directory management , including user account creation, password… more
- Insmed Incorporated (NJ)
- …authority requirements. The role has a strong focus on eCTD publishing and document management within Veeva Submissions Vault, ensuring accuracy, compliance, and ... content and metadata within Veeva Submissions Vault, ensuring compliance with document management standards, version control, and audit readiness.Coordinate the… more
- Merck & Co. (Rahway, NJ)
- …DISTANCE AND BE ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory ... submission process. The main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions… more
- Insmed Incorporated (NJ)
- …in. Are you? About the Role:We're looking for a Summer Intern - IT Program Management : OKR Framework & Delivery Excellence on the IT Team to help us expand what's ... this role, you'll be reporting to the Sr Director, Information Technology Program Management .The Insmed Summer Internship Program is designed to give you more than… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Operations Support Specialist will be part of the Technical Operations...floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …readiness activities.Responsibilities:This individual will be the main point of contact and support all signal management activities. They will lead the safety ... all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily...global Sops. Lead the maintenance of signal tool and support tasks of change control, training material update, and… more
- Insmed Incorporated (NJ)
- …regulatory requirements and ICH guidelines (including E3 and E6), and knowledge of document management systems; is capable of working independently with minimal ... requirements and ICH guidelines (including E3 and E6), and knowledge of document management systems.Familiar with style rules from the American Association… more
- BeOne Medicines (San Mateo, CA)
- …trends that could impact compliance programs. **Regulatory Document Lifecycle Management ** + Support management of regulatory documentation, including ... regulatory information management systems (eg, Veeva RIM) and electronic document management systems. + Experience with compliance monitoring dashboards,… more
- Merck & Co. (North Wales, PA)
- …that enable affordable patient access, deliver insightful customer experiences, and support enriching employee experiences across IAM Contract Management , ... Account Management , and Channel Strategy lifecycles. The Integrated Account Management (IAM) team holds direct account and contract responsibility across the US… more
- Merck & Co. (Philadelphia, PA)
- …the following responsibilities:Development of the integrated evidence strategy to support Health Technology Assessment (HTA) / reimbursement / National Immunization ... and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement and market… more
- Merck & Co. (Rahway, NJ)
- …and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement and market ... that can enhance value and use of our company products.Implements programs to document the burden and cost of diseases, unmet medical need, patient reported outcomes… more
- Merck & Co. (Durham, NC)
- …Set Up, Good Manufacturing Practices (GMP), Manufacturing Processes, Operations Management , Operations Support , Process Improvements, Process Manufacturing, ... Process Monitoring, Production Support , Quality Management , Safety Procedures, Shift Work, Time Management , Written CommunicationPreferred Skills:Current… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor ... with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document trackers generated by the CRO with the document archive.… more
- Merck & Co. (NC)
- …and corporate accounts at our company's Animal Health Area business level, that support our company's Animal Health products and services in their offerings to ... level between our company's Animal Health and strategic account field level management (Regional Director and Medical Directors) Acts as a "connector" in aligning… more
- Cipla (Fall River, MA)
- …execution. In this role the Validation Engineer adheres to the company's document and SOP's procedures while ensuring their accuracy, quality, and integrity. This ... and manages projects to implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends and formal… more
- Cipla (Reid, WI)
- …products in compliance with site SOPs and regulatory guidance. Provides data to support management evaluation of performance trends. Owns quality records (change ... SOP's. In this role the Documentation Specialist adheres to the company's document and SOP's procedures while ensuring their accuracy, quality, and integrity. This… more
- Merck & Co. (Rahway, NJ)
- …Technology will be responsible and accountable for subject matter expert technical support for distribution and logistics of human health Drug Substance, Drug ... experts responsible providing Logistics and Distribution Technology Center of Excellence support to the enterprise.- The leader will be responsible for executing… more
