Monitor updates to EP, USP, Mexico Ph, ChP, and JP.
Analyze changes in compendial requirements.
Ensure timely implementation of compendial changes.
Vertex Pharmaceuticals is focused on the discovery, development and commercialization of medicines. They strive to transform the lives of people with serious diseases.
Drive product registrations in Asia, focusing on East and Southeast Asian countries.
Conduct regulatory assessments of formulas and labels for compliance with country-specific requirements.
Develop market-specific substantiation guidelines for claims and review marketing materials.
Niagen Bioscience uncovers the potential of NAD+ with precision science and creates solutions to help people Age Better. Our collaborative environment embodies "C.H.E.", emphasizing Character, Horsepower, and Experience.
Establishes and maintains a document management system for regulatory electronic files.
Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.
Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.
Responsible for the collection and reporting of data regarding cancer identification, treatment, and follow-up on each eligible cancer patient.
Participates in data quality activities such as peer audits, data edits, and special quality projects as assigned.
Maintains the cancer registry database (s) and generates necessary reports to meet the needs of the cancer registry customers
UChicago Medicine, a world-class academic healthcare system is seeking a Tumor Registrar in the Cancer Registry department. They value passion, talent and commitment… with patients and with each other.
Lead development and execution of pricing and contracting strategy across all commercial channels
Own all government price reporting obligations including Medicaid Best Price, AMP, ASP, and 340B program compliance
Implement and optimize systems and processes to ensure scalable, accurate, and auditable contracting operations
Definium Therapeutics is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint with patient-centric, intelligent individuals.