Review course scripts and assessments for regulatory accuracy.
Identify outdated or unclear content based on current laws.
Recommend improvements to enhance learner comprehension.
EasyLlama is transforming the HR compliance industry by reinventing outdated training solutions for the mobile-first generation, aiming to reduce employee risk and foster inclusive environments. With over 5,000 clients and a 96% rating on G2, they emphasize collaboration, innovation, and a culture of getting things done.
Preparation and submission of regulatory dossiers.
Advise on strategies and registration requirements for product development and marketed products.
Lead regulatory assessment and actions for changes to product and QMS processes.
Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. They have more than 10,000 colleagues and provide products and services in around 90 countries, promising to be forever caring.
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.
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.