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). 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. 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 submitted the first new drug application for a NASH treatment to the U.S. FDA in September 2019. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH. As part of this effort, Intercept is beginning to build a new commercial organization, and this opportunity in our Compliance team will play a pivotal role in preparing the company for the successful anticipated launch of OCA's second indication.
We have an opportunity for a Compliance Advisor to join the team on a 6 Month Contract to assist the International Compliance Department and support duties including providing advice and support to the business (department requestors of HCP/HCO/PAG activities etc) on relevant internal systems, policies and processes to ensure that all business units are in compliance with legal and regulatory requirements. In addition, the Compliance Analyst will assist with the creation and monitoring of training materials and will undertake auditing and monitoring activities (per the regional auditing plan and Global Workplan ) as required by the Director of Compliance, International.
Efficiency, accuracy and excellent communication skills are essential to success in this position.
The Compliance Advisor will report into the Director, Compliance - International.
- Support the Compliance department with day-to-day support activities, including team-wide communications on compliance matters.
- Support business communications and updates (including intranet content/newsletters etc) on relevant compliance matters
- Assist compliance and in house legal advisors in providing compliance support and advice to the various departments of the company
- Assist with team meetings and action recording to support the compliance workplan
- Support creation and updating of business and compliance processes and policies per the compliance program as directed by the regional head of compliance .
- Monitor and record legal and compliance advice requests from the business in the International Region (tracking themes/dates/answers), advising or referring issues on a timely basis to relevant members of the Legal Affairs department as appropriate.
- Assist with the communication and internal tools for compliance (create newsletters,
- Research or summarise legal and compliance issues and draft memoranda as requested
- Other duties as assigned.
Experience and Skills
REQUIRED KNOWLEDGE AND ABILITIES:
- Knowledge of pharmaceutical industry in code of practice compliance matters (UK ABPI Code) or equivalent regulated industry
- Strong verbal and written communication skills are essential.
- Exceptional problem solving capabilities, organizational and multi-tasking skills.
- Auditing /monitoring analysis of data skills
- Excellent interpersonal, communication and written skills, proven ability to work and interact with a wide range of stakeholders, vendors, customers and internal employees of all levels from a number of countries and cultures given the advisory nature of the role
- Ability to work independently and build strong networks throughout the organization.
- Ability to work effectively across a matrix organization.
- Ability to work independently and prioritize with minimal daily instruction.
- Ability to think strategically in order to improve current processes.
- Limited business travel may be required initially. This may change as business needs evolve.
- Experience in life sciences industry or related business is preferred.
- Demonstrable prior work experience, preferably at Pharmaceutical Company
- Knowledge of compliance regulations and industry guidance, such as UK Anti-Bribery, transparency laws, EFPIA Code, ABPI Code and similar laws, regulations and industry standards in Europe strongly preferred
- Legal and/or project management qualifications are not necessary but preferred.
To apply for this interesting opportunity, please send a CV and cover letter no later than Friday 4th September