Healthcare & Pharma Careers
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We are seeking a Regulatory Affairs Specialist in pharmaceutical Licensing for our client in Northeast Atlanta.. The role includes managing state pharmaceutical licenses for wholesale drug distribution, verifying client licenses, and supporting regulatory and Quality Assurance initiatives.. Experience with electronic Quality Management Systems (QMS) (preferred).. Regulatory Affairs certification (e.g., RAPS Medical Devices/Pharmaceuticals) (preferred).. Occupational Category: 13-1041.07 - Regulatory Affairs Specialists
Collaborate closely with cross-functional teams, including clinical operations, clinical development, biostatistics, pharmacovigilance, and regulatory affairs, to ensure alignment between medical writing activities and program goals.. Support medical affairs to ensure alignment between publications and congress presentations and clinical documents.. Qualifications and Skills Required: 10+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development.. PhD or PharmD in Scientific Area preferred.. Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies.
Ranked #1 for Safety, Quality and Patient Satisfaction, Jupiter Medical Center is the leading destination for world-class health care in Palm Beach County and the greater Treasure Coast.. Coordinates and/or completes applications for initial submission to the Institutional Review Board (IBC) for review including assisting with protocol development activities, completing required application forms, and creating consent forms to meet JMC and sponsor standards.. and respond to Institutional Review Board requests.. Analyze and submit unanticipated adverse events (AEs) and serious adverse events (SAEs) and deviation reports to the IRB as required by sponsors and, if appropriate, make changes to the consent form to reflect new information about adverse events; provides support to internal/external staff in completing AE or SAE reports for submission to study sponsors and IRB.. Serves as information specialist and resource for regulatory, ethical and methodological questions and issues from staff.
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
Enjoy problem-solving, need a venue to display your creativity, and emerging technologies pique your interest; if so, Barrow Wise Consulting, LLC is for you.. Barrow Wise is an equal-opportunity, drug-free employer committed to diversity in the workplace.. Minority/Female/Disabled/Protected Veteran/LBGT are welcome to apply.. Our employees stand behind Barrow Wise's core values of integrity, quality, innovation, and diversity.. We are confident that Barrow Wise's core values, business model, and team focus create positive career paths for our employees.
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
About Madrigal: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH).. Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts.
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
The ideal candidate will have experience in regulatory affairs or quality assurance, with a focus on medical devices.. This internship offers an excellent opportunity to gain hands-on experience in the regulatory aspects of the water treatment industry while contributing to critical compliance and documentation processes.. Coordinate with Quality Assurance, Plant Manager, and Quality Control teams to review technical documents for FDA submission. Assist in the validation of CAPA processes, including documenting changes to product lines and plant renovations. Currently enrolled in an undergraduate program with a focus in BioChemistry, Chemistry, Biology, or another related field
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
Assess the acceptability of quality, preclinical and clinical documentation for submission filing.. Requirements: Bachelor's Degree in Science (Biology; Chemistry; Microbiology; Immunology; Medical Technology; Pharmacy; Pharmacology); Math; Engineering; or Medical fields is preferred.. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.). Individuals with "hands-on”/authoring experience with US k submission or EU MDR/IVDR technical files.. Individuals with practical experience working with in vitro diagnostics medical devices.
With a newly qualified manufacturing facility and plans to scale production, we are seeking a Head of Quality Assurance and Regulatory Affairs to ensure compliance and excellence in quality and regulatory practices.. Position Overview: The Director of Quality Assurance and Regulatory Affairs will oversee the quality management system (QMS), ensure compliance with global medical device regulations, and provide strategic leadership to the quality and regulatory teams.. Qualifications: Bachelor’s degree in Engineering, Quality Management, Regulatory Affairs, or a related field; advanced degree preferred.. Strong knowledge of global medical device regulations, including FDA and ISO/CE standards.. Experience managing QMS compliance, regulatory submissions, and product lifecycle management.
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This Senior Regulatory Affairs Specialist will work out of our Alameda, CA location in the Diabetes Care Division.. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department to ensure efficient and compliant business processes and environment are followed.. Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed.. 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.
Job Title: QA/RA Manager (Quality Assurance and Regulatory Affairs Manager) - IVD. Ensure that all in vitro diagnostic products meet applicable quality standards, including the management of product development, manufacturing processes, and validation activities.. Qualifications: Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field (Master's or MBA preferred).. Strong understanding of the IVD product lifecycle, from development to post-market surveillance.. Certification in Regulatory Affairs (e.g., RAC) or Quality Management (e.g., Six Sigma, ASQ Certified Quality Manager) is a plus.