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

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

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

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

Site Name USA Pennsylvania Upper Providence, Durham Blackwell Street, GSK House, Rockville Biopharm, Stevenage, UK Hertfordshire Ware, Waltham, Zug House Posted Date Feb 22 2024 Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting opportuni

/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

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,

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

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

This position is for weekend evenings Reporting to the Pharmacy Services Manager and under the direct supervision of the registered pharmacists, assists in the preparation and filling of medication orders, perform critical pharmacy calculations, compound non sterile products using proper technique, utilize various software programs and technical equipment for the various

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

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Job Summary This position is responsible for site packaging equ

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

Site Name USA Pennsylvania Upper Providence Posted Date Apr 1 2024 We are looking for a highly motivated, flexible and experienced scientist to join the Cellular Biomarkers Flow Cytometry team within Biomarker & Bioanalytical Platforms in the Precision Medicine department located in Upper Providence, US. The team is responsible for the development and validation of comple

We are looking to fill a Sr. Scientist 1 position working as a full time employee of Parexel FSP on long term assignment onsite at one of our clients located in Kenilworth, NJ. Ongoing assignment, no end date This position offers salary, full benefits, sick time, 401K, paid holidays, and paid time off. Description Support of routine bioanalytical testing of samples from c