Prepares /oversees the preparation of various regulatory submissions including Pre Submissions, 510(k) submissions, CLIA Waiver Applications, Dual 510(k)/Waiver by Applications, technical files, and license applications. Monitors new and changing regulations and guidance and disseminates information to stakeholders. Identifies regulatory trends and conducts key regulatory

SHIFT Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply t

Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sus

What this job involves Join JLL for a great opportunity to support a world class life sciences client. The Sr. Manager, Planning & Scheduling is a new investment role and will be responsible for the management of a large team of site based planners and schedules across a network of facilities located throughout United States and Puerto Rico. All work performed is in accord

This role is responsible for coordinating the customer specification review process among team members and performing specification reviews. Serve as a liaison with Plant Quality Managers, Sales, Technical Customer Service, customers & other groups necessary to obtain the information needed to complete specification reviews. Draft West master specifications and maintain e

The Institute on Disabilities at Temple University is seeking a dynamic, passionate, innovative thinker and person of action to lead our statewide federal Assistive Technology (AT) Act program, known as TechOWL. The Institute's team members engage in meaningful work that advances individuals and communities impacted by disability. The AT Program uses a social service mode

Singular talents thrive as an Associate Director of Medical Writing with Caudex. We advocate. We captivate. We cogently demonstrate. We combine gravitas with that lightness of touch that only comes from genuine, deeply held mastery and passion. We're recognised leaders in our field because we make the extraordinary seem effortless. We are your people. You're a recognised,

/JOB PURPOSE Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. Essential Duties And Responsibilities Review clinical site regulatory documents t

This position is for a postdoctoral researcher in the Ellison laboratory to perform functional genomic experiments related to the study of genome organization in Drosophila. Position Status Posting Number 19FA1340 Posting Open Date Posting Close Date Qualifications Minimum Education and Experience PhD is required along with knowledge of ChIP seq and other functional genom

Validate, andutilizechromatographic tandem mass spectrometric assays and ligand binding assays to measuredrug levels in biological matrices to support sample analysis. Responsible for method validation, and preclinical sample analysis. Ensure GLP compliance. Supportassayprotocol andvalidationreport preparation. Communicate results effectively to team members and supervisi

PHARMACIST CONSULTANT Job Locations US PA BETHLEHEM | US PA HORSHAM | US PA HARRISBURG ID 2024 142022 Line of Business PharMerica Position Type Full Time Pay Min USD $56.00/Hr. Pay Max USD $60.00/Hr. Our Company PharMerica Overview Our Pharmacy group focuses on providing exceptional customer service and meeting the pharmacy needs for hospitals, rehabilitation hospitals, l

The Senior Director, Medical Affairs will provide global medical leadership for the R&D function of the Fresenius Kabi MedTech business, which includes medical devices and solutions associated with transfusion, cell therapies, and infusion technology. Participate in and guide risk management inputs for development projects, support definition and execution of clinical dev

The Lewis Katz School of Medicine's Department of Thoracic Medicine and Surgery is searching for a highly motivated Associate Scientist with a strong interest in translational research. The Associate Scientist performs experiments based on predetermined research protocols and objectives, under the guidance of Joseph Friedberg MD, in his Thoracic Surgery Research Laborator

The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next generation technology for cellular therapy. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively