Responsibilities: Provide comprehensive data management support to the Center for Cancer Research/CCR intramural clinical trials program. Manage the delivery of high-quality data from project start-up and planning to project execution an...
Responsibilities: We are seeking a skilled Validation Engineer with experience in GxP compliance and expertise in 21 CFR Part regulations. The ideal candidate will have a strong background in life sciences and experience in qualifying an...
Responsibilities: Partner with client Commercial Sales and Marketing, Market Access, Commercial Operations, and other stakeholders to implement Veeva CRM and related technology solutions in alignment with key business priorities. Config...
Responsibilities: Act as Lead Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studies. Interact and manage relationships with other functional areas to ensure high quality data management activi...
Coordinate with the India Engineering Center (IEC) and enable successful project execution and have a daily sync with the offshore team and IEC leadership Perform a full lifecycle product development (Design, Develop, test prototypes, and ...
Summary: Research and test the design, functionality and maintenance of products, equipment, systems and processes and develop quality standards. Ability to read and interpret blueprints, and evaluate product integrity and standards. Typica...
Responsibilities: Partner with client Commercial Sales and Marketing, Market Access, Commercial Operations, and other stakeholders to implement Veeva CRM and related technology solutions in alignment with key business priorities. Config...
Responsibilities: Independently support data maintenance and archival and retrieval of regulatory documentation in computerized systems. Assist with preparing high quality US regulatory submissions required by local and federal agencies ...
Responsibilities and Requirements: Seeking Supply Chain Planner skilled in Project management to support Client Brand Transition program. Drive global supply chain project management of supply planning activities to implement previous Cl...
Responsibilities: This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs. Review individual complaints and asso...
Responsibilities and Requirements: Manager of Regulatory Compliance will support the Sr. Director of Regulatory Process and Compliance in maintaining client's compliance with regulatory requirements. This role will focus on assisting wit...
Responsibilities: Looking for an R statistical programmer/analyst to support a small biotech. There is not a computing environment set up yet so the person will use the RStudio desktop app and leverage R (like R Shiny) for data visualizat...
Responsibilities and Requirements: The Brand Transition program executes in two phases with a program manager to cross-functionally track the execution across all SKUs x all countries x all functions. With Phase 1 labelling executing to ...
Responsibilities: Scope of Services: SDTM, ADaM, and TLF production and/or validation, Ad-hoc from statistics and/or other related programming requests and other statistical programming needs as requested by Company to support all clinica...
The incumbent will be a part of the IT Computerized System Validation (CSV) Department and will perform and/or direct GxP computerized system validation projects in compliance with cGMP, 21 CFR Part 11 and Annex 11. This individual will ens...
Responsibilities: Oversee the global strategy for the Learning Management System, ensuring it supports the company's strategic objectives and global training needs. Collaborate with regional stakeholders to ensure LMS processes are stand...
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...
Responsibilities: Provide Quality oversight for the Commercial stage, including Design Transfer. Create/revise/execute SOPs to support combination product quality governance in the commercial stage. Evaluate design changes and provide q...
Responsibilities: Partner with client Commercial Sales and Marketing, Market Access, Commercial Operations, and other stakeholders to implement Veeva CRM and related technology solutions in alignment with key business priorities. Configu...