Job Title: Compliance Training Manager
Location: UK (Remote)
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 marketed under the brand name \"Ocaliva®\" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.
Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2021.
People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.
At Intercept, we foster an environment that celebrates creativity, collaboration, and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.
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 Compliance Training Manager.
The Compliance Training Manager can be based anywhere in the UK, and will report to and work closely with the Chief Compliance Officer and multiple internal departments (Human Resources, Quality, Commercial, etc.) to develop and maintain a comprehensive training program consistent with law, the Company's policies and best practices. The Compliance Training Manager must have strong project management skills in order to coordinate, organize, document and communicate about successful development and deployment of training. They will lead cross-functional projects with multiple departmental stakeholders with respect to the Company's training matrix, programs, and employee mapping. This person will also be responsible for the conducting of live training as needed. The Compliance Training Manager will regularly report to the Chief Compliance Officer and executive management.
The successful candidate must be able to perform each of the following satisfactorily:
- Design, development, administration, and oversight of the Company's global compliance training program.
- Work collaboratively with technical and functional Subject Matter Experts to convert training materials to web-based training using Adobe Captivate for deployment using SABA Cloud Learning Management System (LMS).
- Create effective web-based training by utilizing several types of media such as, graphic design, animation, audio, video, assessments and other interactive exercises.
- Author and/or revise customers course scripts and storyboards in order to create comprehensive and effective learning - including assessments / knowledge checks.
- Utilize a standard development process for SCORM, author and test resulting in enhanced tracking accuracy and overall training.
- Identify and document training gaps, issues, constraints, and process concerns with existing and new workflows.
- While administering the program, the candidate will have the ability to conduct ad-hoc live training or training via video conferences.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team.
- Regularly report to the Chief Compliance Officer and executive management on the status and progress of the Company's global training program.
- Other duties as assigned.
- Drive the spirit of \"ONE Team\" across all functions by supporting a team approach to focus on our patients and customers as our top priorities.
- Make Intercept a truly desired place to work.
Experience and Skills
- Bachelor's degree and 4 or more years prior work experience, preferably at a global commercial-stage pharmaceutical company.
- Training, presenting, and project management experience.
- Ability to work independently and to build strong networks with management, employees, and Company vendors.
- Experience building or administering Compliance training programs.
- Travel required of 10-25%.
REQUIRED KNOWLEDGE AND ABILITIES:
- Requires advanced computer skills (e.g., LMS software systems, generating spreadsheets and database management - e.g., Adobe Captivate Web-based training development, SABA Cloud LMS)
- Knowledge of compliance regulations and industry guidance, such as Anti-Kickback, False Claims Act, Foreign Corrupt Practices Act, UK Anti-Bribery, PhRMA Code, EFPIA Code, ABPI Code and similar laws, regulations and industry standards in the United States and Europe is preferred.
- Proven ability to work with a wide range of stakeholders, including domestic and international employees.
- Strong verbal and written communications skills
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Come Together, Be Yourself, Own the Solution, Embrace the Challenge, Keep Exploring
- Understanding the legal and compliance environment
- Ability to have fun and thrive in a growing, diverse and inclusive work environment
This is a fantastic opportunity to join a dynamic organization, where you will enjoy a high level of autonomy and chance to work innovatively. Competitive remuneration on offer.
To apply, please send a CV and cover letter before Monday 10 th January