At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name \"Ocaliva ® ,\" is approved in the U.S., EU and Canada for certain patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first product to be approved for PBC in over twenty years and our team is proud to have been pioneers in providing the first second-line treatment option to patients with such critical need. The Ocaliva ® launch in 2016 also marked Intercept's successful transition from a development-stage company to a fully integrated commercial organization with continued growth.
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH), which impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.
As Intercept continues to build its position as the leader in progressive non-viral liver disease and pursues its goal of bringing the first approved therapy to patients with NASH, we are seeking a Manager, GxP Training Development and Management, requiring knowledge and experience in the execution of training and development process within a GxP regulated environment. This person should be able to:
- Further enhance and develop existing learning management system to align with industry expectations and regulations
- Challenge status quo and develop innovative, \"out of the box\
Experience and Skills
- Bachelor's degree with minimum 8 years related work experience administering a Learning Management System (LMS)
- 8+ years related experience in utilizing an electronic document/quality management system in a GxP environment
- Demonstrated knowledge and experience with development, implementation or maintenance of electronic learning initiatives including but not limited to, testing mechanisms; blended learning; and curriculum development within a GxP environment.
- Ability to work independently.
REQUIRED KNOWLEDGE AND ABILITIES:
JOB RELATED KNOWLEDGE AND SKILLS (minimum levels required to meet the expectations of the position):
- Individual must be detailed oriented and have excellent organizational skills.
- Individual must be able to multi-task, work on several projects simultaneously and prioritize accordingly. Individual must have excellent verbal and written communication skills.
- Outstanding presentation and interpersonal skills with the ability to work collaboratively and communicate effectively with all levels of an organization.
- A team-oriented approach to the work environment.
- Strong written communication, verbal communication and training skills.
- Individual must have the ability to manage to multiple compliance standards as we are currently regulated by: ICH, FDA, Canadian, EU, etc. regulatory standards and guidelines.
- Knowledge and work experience with electronic Quality Management Systems such as Master Control.
LAB EQUIPMENT AND COMPUTER EXPERIENCE AND LEVEL OF PROFICIENCY (minimum required to meet the expectations of the position):
- From a technology perspective must possess proficiency with MS Office products including Word, Excel, PowerPoint and Outlook.
- Proficient in Adobe Design Suite (Photoshop, Illustrator, Captivate, InDesign).
- Individual should have experience with development and/or implementation of electronic documentation/quality systems but must have experience with managing validated computer systems and working with LMS.
COMMUNICATION & LANGUAGE SKILLS (type and frequency of interactions with others as well as any language requirements):
- Command of the spoken and written English language is required. Must be articulate and able to communicate effectively with employees at all levels of the organization on the telephone and in person.
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Understanding the legal and compliance environment
- Ability to have fun and thrive in a growing, diverse and inclusive work environment