Manager, GxP Training Development

Job Description

POSITION SUMMARY :

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 & non-GxP Training Development, requiring knowledge and experience in the execution of training and development process within a GxP & non-GxP regulated environment. This person is responsible for:

• 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
  
  QUALIFICATIONS:
  
  
  • Bachelor's degree with minimum 5 years related work experience administering a Learning Management System (LMS)
  • 5+ 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 :
  

  • 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.
  • 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.
  • 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.
  • Strong verbal and/or written communications skills
  • Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
  • Consistent demonstration and embodiment of our company core values: Come Together, Be Yourself, Own The Solution, Embrace The Challenge, and Keep Exploring
  • Ability to have fun and thrive in a growing, diverse, and inclusive work environment

  
  
  COMPANY CULTURE:
  
  People at Intercept are passionate about patients. You'll see our patient photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member from all dimensions of diversity feels included and has the opportunity to reach their potential. We recognize the power of a diverse, equitable and inclusive (DEI) work force, and how it enriches the professional lives of our team members. Diversity, Equity, and Inclusion drives innovation and connects us to the patients and communities we serve.
  
  At Intercept, we foster an environment that celebrates creativity, collaboration, and mutual respect. We never hesitate to lean on our teammates and work together. As we grow, we want to make every effort to provide a safe and open environment for professionals of every background and provide knowledge on how to work inclusively and equitably to make Intercept a great place to work.
  
  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. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.
  
  COMPANY SUMMARY:
  
  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. In 2016, Ocaliva ® was the first medication to be approved for PBC in over twenty years, and sales continue to grow.
  
  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 and for which there are currently no available treatments. In December 2022, Intercept re-submitted its NDA for fibrosis due to NASH to the FDA based on positive data from its phase 3 REGENERATE trial.
  
  COMPENSATION & BENEFITS :
  
  The anticipated starting salary range for this position is $110,000 to $164,000. This represents the anticipated low and high end of the salary range for this position. Actual salaries will vary and may be above or below the range, based on various factors including, but not limited to, experience, skillset, and performance.
  
  The salary range listed is just one component of our total compensation package. Successful applicants will be eligible to receive annual bonuses and equity in the Company, at the discretion of the Company. Intercept also provides a competitive suite of benefits, including:
  

  • 401(k) plan with company match
  • Rewards and recognition program
  • Health care benefits (medical, Rx, dental, and vision insurance)
  • Sick and safe leave (unlimited, subject to certain limitations, and in accordance with disability coordination, as applicable)
  • Parental leave benefits
  • A generous Paid Time Off program of 20 days per year
  • 10 paid holidays per year
  • 4 paid Personal Days per year
  • 2 paid Volunteer Days per year
  • Numerous well-being and work-life programs

  
  EEO Statement
  
  Employment decisions at the Company are made without unlawful regard to race, color, religion, creed, national origin, alienage or citizenship status, sex (including gender, pregnancy, childbirth or medical conditions related to pregnancy or childbirth), gender identity or expression, sexual orientation, national origin, ethnicity, age, physical or mental disability, legally protected genetic information, marital or partnership status, sexual and reproductive health decisions, military or veteran status, or any other status protected by applicable federal, state, or local law.