- Tris Pharma (Monmouth Junction, NJ)
- …throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration ( FDA ), Drug Enforcement Administration ... sourcing, contract negotiation, and supplier management Strong knowledge of FDA regulations, current Good Manufacturing Practices (cGMPs) and pharmaceutical supply… more
- Tris Pharma (Monmouth Junction, NJ)
- …Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration ( FDA ) standards. She/he also provides and monitors ... is cleaned to meet production schedule and in accordance to strict SOP, FDA and cGMP standardsSupports and assists with daily cleaning functions, as needed (vaults,… more
- Eisai, Inc (Phoenix, AZ)
- …laws and regulations impacting the pharmaceutical industry (eg, PhRMA Code; Federal Food , Drug , Cosmetic Act; Anti-Kickback Statute; False Claims Act, OIG/DOJ ... learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with office management to provide various informational… more
- Northwestern University (Chicago, IL)
- …& procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration ( FDA ) Code of Federal Regulations (CFR), & the International ... scientific papers for presentation & publication & coordinates writing, submission & administration of grants. Ensures that all study activities are completed by… more
- Cedars Sinai (Los Angeles, CA)
- …compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Maintains research ... field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures,… more
- ADMA BIOMANUFACTURING LLC (Boca Raton, FL)
- …and evaluating regulatory documents for submission to the US Food and Drug Administration ( FDA ). This position provides advice and direction regarding ... inspections to ensure appropriate information is supplied as requested. Accompanies FDA inspectors for pre-scheduled new and routine center audits as directed.… more
- Cedars Sinai (Beverly Hills, CA)
- …compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Maintains research practices… more
- Hims and Hers Health, Inc. (Gilbert, AZ)
- …rules as designated by the Arizona State of Pharmacy and the Food and Drug Administration ( FDA ) Maintain a clean and sanitary work environment as ... mandated by the FDA 's rules and regulations Provide a world class pharmacy...one of our patients Perform pharmacist duties such as drug utilization reviews, patient counseling, and dispensing activities Completes… more
- Abbott (Minnetonka, MN)
- …(EMS), and other regulatory requirements Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company ... goals and aligned with Lean Manufacturing principles and in compliance to FDA and all other applicable agency regulations Develop the initiatives that support… more
- Cedars Sinai (West Hollywood, CA)
- …compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Maintains research ... practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and… more
- Charles River (Wayne, PA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their… more
- Abbott (Minneapolis, MN)
- …(EMS), and other regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company ... policies, operating procedures, processes, and task assignments. Shift Monday - Thursday, 5:15 am - 3:45 pm with potential overtime Required Qualifications High School diploma or equivalent. Five years or more of medical device or related assembly experience.… more
- MEITHEAL PHARMACEUTICALS INC (Los Angeles, CA)
- …branded products. Meitheal currently markets over 60 US Food and Drug Administration ( FDA )-approved products across numerous therapeutic areas including ... products planned for launch in 2025, and 24 products under review by the FDA . Meitheal's mission is to provide easy access to fairly priced products through robust… more
- Granules Pharmaceuticals (Manassas, VA)
- …direction from leaders Follow Current Good Manufacturing Practices (cGMP) Food and Drug Administration ( FDA ) and other regulatory requirements. Must be ... able to read, write, communicate and understand English proficiently. Legible handwriting Understand and adhere to Standard Operating Procedures for process rooms and manufacturing area. Ensure GMP compliance in a regulated work environment. Follow… more
- Nemours Children's Health (Wilmington, DE)
- …Representative to oversee implementation and compliance with the Food and Drug Administration ( FDA ) REMS Program requirements for KYMRIAH Chimeric ... Antigen Receptor (CAR) T-cell Therapy. Ensures NCH, DE adheres to Novartis mandated requirements of a certified site. Collaborates with various internal and external entities such as the American Red Cross, Registry Partners, the NCH, DE Stem Cell Laboratory… more
- Globus Medical (Audubon, PA)
- …for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This ... position entails development of FDA submissions, requiring working knowledge of products under review...in building working relationships with internal teams while following FDA 21 CFR regulations. Essential Functions : Partnering with… more
- Abbott (Pleasanton, CA)
- …and regulatory requirements of Abbott, FDA and ISO regulations Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory ... requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors Perform other related duties and… more
- St. Louis County, MO (St. Louis, MO)
- …condition of employment. Full vaccination means having received a Food and Drug Administration ( FDA ) Emergency Use Authorization (EUA) approved vaccine ... merit position will be required to submit to urinalysis to screen for illegal drug use prior to appointment. Screening will be performed by a reputable clinical… more
- Sutter Health (San Francisco, CA)
- …Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). Ability to ... pharmacy, the drug enforcement administration , and the food and drug administration by assisting Pharmacists in monitoring nursing unit inspections;… more
- Abbott (Minneapolis, MN)
- …(EMS), and other regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, international regulations and other regulatory ... and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates. Maintains… more
