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 potent 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 use in primary biliary cholangitis (PBC), a rare autoimmune liver disease. OCA is also being investigated as a treatment for nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to NASH. REGENERATE is the first and largest Phase 3 study in NASH a chronic disease that threatens the lives of millions of people in the U.S. alone. By 2020, NASH is expected to overtake hepatitis C as the leading cause of liver transplants in the U.S. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.
Based on the positive results from REGENERATE, Intercept intends to file for regulatory approval in the U.S. and EU in the second half of this year. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH.
The Clinical QC Specialist resides within Clinical Medical Writing. This is a full time position that will function in a matrix structure, providing a corporate data and document integrity review (QC) resource for Medical Writing. This position may also provide broad technical and scientific support within Clinical Development.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
Execution of a QC program to ensure effective quality reviews of data, interim and/or final reports, protocols, amendments for regulatory agency submission
Operate in a true matrix structure to ensure appropriate prioritization and support of document integrity review of documents from various departments within Intercept
Build strong strategic relationships
Participate in the implementation of effective solutions to quality issues or problems
Assist writing and/or updating guidelines related to QC activities across various functions
Update or assist developing processes and workflows, as necessary
Expert user of Microsoft Office word processing, presentation, and spreadsheet software; knowledgeable about electronic document management systems, Sharepoint, Adobe Acrobat and Prism
Perform all duties in keeping with Company's core values, policies, and applicable regulations.
Other duties as assigned to assist within Medical Writing
BS Degree (biology or chemistry preferred) with at least 6 years of pharmaceutical/biotech experience, or master's degree with at least 4 years of pharmaceutical/biotech experience
At least 3 years of document QC/review experience
Experience in multiple therapeutic areas, with prior experience in hepatology, gastrointestinal or related field, preferred
REQUIRED KNOWLEDGE AND ABILITIES:
Advanced applied knowledge of the following:
Experience in quality control and/or quality assurance of regulatory submissions/aggregate reports within the pharmaceutical industry is critical
Demonstrated analytical skills and extremely high attention to detail
Demonstrated strength in oral/written communication and interpersonal skills; team player
Demonstrated organizational skills
Excellent skills in the following areas:
Advanced functional experience in the following computer applications:
Intercept Pharmaceuticals, Inc.