Jobs in All Categories (33) Accounting & Finance (3) Engineering & Construction (2) Healthcare (2) Human Resources & Legal (1) Marketing, Media & Design (4) Operations & General Management (4) Project Management (1) Science & Education (11) Technology (5)
Oversee and manage the development and implementation of edit check specifications and work with CRO during programming & validation.
Retain secure access to the US Medicare database and conduct data and analytic evaluations following an approved study protocol.
Assist in conducting research on emerging products, services, protocols and standards in support of Services Desk technology procurement and development efforts.
Participate in requirement gathering efforts to provide feedback on technical feasibility and viability in additional to best practices for Veeva.
Work with external contractor / vendor network to ensure on-going quality and compliance. This would also include periodic audits.
Interpreting business data being monitored and analyzing results using statistical techniques and creating comprehensive data reports.
Communicating deviations identified through monitoring to the business, and providing it with tailored remedial training and/or suggested process/procedural changes to help prevent further deviations.
Provide Regulatory direction for the coordination, and preparation of Regulatory submissions consistent with Regulatory requirements to meet corporate strategy & timelines.
Support all Strategic Sourcing to develop and support the short and long-term sourcing plans, utilize procurement operations platforms and vendor strategies in partnership with primary stakeholders.
Drive the timely preparation of budgetary, forecast and long-range planning cost inputs to the overall process. Analyze cost savings opportunities, develop project plans and monitor progress and results.
Support development and execution of patient initiatives, including Public Relations and Advocacy Group partnership management.
Serves as the leader and coordinator for the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.
Understand clinical data and use text, tables, and figures as appropriate to accurately and effectively convey key messages.
The Process Engineer II/III will have responsibility for process development, process characterization, scale-up, and technology transfer activities, supporting new and existing pharmaceutical products.
Collaborate with the Sr. Director Supply Planning to set the strategy for analytics, reporting and global supply planning as well as budget reporting.
Provides medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on clinical studies, before during and after conduct of studies, and identify/resolve issues related to study design that arise during study.
Identify opportunities to enhance performance; e.g. pull-through, treatment adherence, resource allocation, co-pay program.
Lead the execution of Professional Education programs including facilitation, coordination and management of vendors to ensure that programs operate efficiently, effectively and compliantly.
Develop the field-based clinical educator role profile, and collaborate with external partner, to hire, train and coach the clinical educator team.
Responsible for adequate and up to date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents.
Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development as appropriate.
The person will be responsible for managing a group of scientists and independently driving research programs across the different stages of pre-clinical drug discovery.
Support all Strategic Sourcing and Purchasing Operations to ensure supplier master maintenance, sourcing project panning, supply chain and inventory management analysis, spend analysis, transaction support and buying tool development to build and maintain a competitive advantage in procurement and supplier management.
Interprets complex data and solves scientifically challenging problems by providing direction and leadership in the AR&D Laboratory.
Conduct prior art searches for patentability and freedom to operate analyses related to the Company's product candidates and research efforts.