Senior Analyst, Compliance at Intercept Pharmaceuticals Inc. in New York, New York

Job Description:

Job Description

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. 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.

POSITION SUMMARY:

As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Compliance Senior Analyst who will assist with the implementation of a global compliance and ethics program, including the implementation of systems, programs, processes, and practices to ensure that all business units are in compliance with legal and regulatory requirements. The Senior Analyst is responsible for the data analytics that is required to support all business areas in complying with healthcare professional (HCP) and healthcare organization (HCO) spend disclosure laws and regulations. The Senior Analyst serves as a data quality analyst and a business liaison for the data collection and reporting processes. The Senior Analyst assists with the creation of training materials and with developing and implementing a compliance auditing and monitoring plan designed to mitigate risk. The Senior Analyst will prepare updates, presentations, and compliance reports for top management based upon processes and implementation.

A successful candidate will rely on experience and judgment to plan and accomplish goals. Efficiency, accuracy, and excellent communication skills are essential to success in this position. This position reports to the Director of Legal Compliance.

CORE ACCOUNTABILITIES:

The successful candidate must be able to perform each of the following satisfactorily:

• Support Intercept in transparency reporting globally, including assisting with the implementation of a transparency system.


• Review expense reports flagged for review from T&E system and follow up with appropriate personnel to resolve discrepancies. Support projects and programs related to Aggregate Spend and Transparency associated with: HCP Marketing and advertising payment information, grants and charitable contributions, clinical investigations, and R&D payments.


• Assist with the compilation and submission of the annual report for Open Payments and various reports around the world. Assist with the HCP/HCO dispute resolution process.


• Assist with the creation of business and compliance processes and policies to support the compliance program.


• Serve as a compliance monitor, work independently with ICPT team members worldwide and outside advisers to set up policies and processes for transparency, and other general compliance matters, attend events, and complete appropriate documentation.


• Other duties as assigned.


• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team


• 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

QUALIFICATIONS:

• A bachelor's degree in a science related field or equivalent with experience in a biopharmaceutical environment. Experience in a commercial entity is highly valued.


• Minimum of 5 years applicable work experience, preferably at a global pharmaceutical company.


• Proficient in data analytics.


• High-level of familiarity with a broad range of compliance risk areas, relating to a global biopharmaceutical company.


• Knowledge of compliance regulations and industry guidance, such as Anti-Kickback, False Claims Act, Foreign Corrupt Practices Act, UK Anti-Bribery, US Sunshine and transparency laws, PhRMA Code, EFPIA Code, ABPI Code and similar laws, regulations and industry standards in the United States and Europe.


• Previous experience with US Sunshine and similar transparency requirements around the world such as EFPIA codes.


• Excellent interpersonal, communication and written skills, proven ability to work with a wide range of stakeholders, including internal personnel from a number of countries and cultures.


• Strong presentation and training skills and ability to work independently and build strong networks throughout the organization.


• Ability to effectively work with and manage a number of vendors supporting the Company's compliance efforts across the world.


• Interact with senior management, employees at all levels, vendors and customers.


• Up to 15-30% travel variable may be required, dependent on ordinances related to COVID-19.


• Ability to work onsite (New York, NY), dependent on ordinances related to COVID-19.

• Global transparency knowledge.


• Excellent organization and multi-tasking skills.


• Exceptional interpersonal skills and problem-solving capabilities.


• 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.


• 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: 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

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