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Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required...
As the subject matter in quality control operations, they will provide technical support to external and internal departments regarding microbiological inquiries for new product development...
Assist product and process development groups in solving technical problems involving formulation composition, efficacy, stability, etc. Assist product, process and groups and manufacturing facilities...
Identify and interpret preclinical and clinical data critical for model development and refinement. Maintain state-of-the art knowledge of relevant modeling approaches and techniques...
This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety information in worldwide package circulars. The incumbent is also responsible...
Collaborates effectively with Process Chemistry, Discovery Process Chemistry, Enabling Technologies, Chemical Engineering Research & Development (R&D), Analytical R&D, Quality, and other of our Compan...
Lead cross-functional Real World Evidence team consisting of internal partners with the clear objective to deliver scientifically valid and robust evidence to support all stages of product development...
Oversees performance and reviews, modifies, and approves or disapproves techniques/processes by said staff to ensure compliance with appropriate research methodology and statistical techniques. Carrie...
Assures compliance with all appropriate Institutional, State and Federal regulatory agencies. Participates in aspects of protocol review, protocol implementation, subject screening, enrollment, manage...
Internal: scientists, clinicians, and project leaders in therapeutic areas, operations group (clinical trial managers), data managers, study biostatisticians, representatives from Regulatory Affairs...
Designs, and conducts early clinical development studies within planned timelines (supported by an operational team).
Responsible for tracking group performance and driving continuous improvement. Understand how to organize people, including contracted off-site scientists in order to deliver on goals...
Generate PUMA documents required for system development in particular requirements specification, validation strategy and user acceptance testing. These documents are needed for the development/mainte...