at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
This position reports directly to Incyte's Chief Compliance Officer and is responsible for management and oversight of Incyte's Global Corporate Compliance Program, including responsibility for Incyte's ex-US affiliates and network of strategic partners and distributors. The role is located in Incyte's global headquarters and requires significant interaction with Incyte's Global and Regional Legal, Product Strategy, Information Technology, Medical Affairs, Product Strategy, Research and Development, and other company departments. This position will work to continuously enhance Incyte's Compliance program through application of best practices in the life sciences Compliance space.
Essential Functions of the Job (Key responsibilities)
Partner with business units to maintain an infrastructure that supports a company culture of compliance and recognizes that compliance is a collective responsibility of the all company employees.
Develop tools, processes and reports to support the business's ownership of Compliance
Provide guidance to the business and integrate compliance controls into the scope of existing business practices company-wide.
Work with the Chief Compliance Officer to coordinate the development and implementation of Incyte's internal Compliance processes to enhance and streamline policy, training, auditing, risk assessment, monitoring and investigation activities with a view toward global harmonization, automation and effective reporting.
Responsible for managing Incyte's ABAC Compliance program including applicable policies and training as well as systems/processes used to support Incyte's third party screening and diligence activities.
Coordinate with Incyte's Internal Audit and Compliance Monitoring functions to develop plans for ex-US audit and monitoring activities
Coordinate with Incyte's Compliance Risk function to develop annual risk assessments and build new risk assessments to address business expansion.
Responsible for Compliance support of Business Development activities (licensing, distributor and M&A arrangements) including due diligence, contract negotiation and ongoing support of compliance relationships with Incyte's strategic partners (running quarterly compliance meetings, maintaining compliance charters and certifications, developing a plan for partner reports, etc.)
Oversee and lead Incyte's regional/country compliance programs and manage regional/country compliance leads.
Act as business facing Compliance lead for Incyte's global, HQ-based functions including Global Medical Affairs, Development Operations, Publications and Global Product Strategy including responsibility for Compliance policies and training for these functions.
Provide regular updates and reports to the Chief Compliance Officer, the Compliance Committee, and senior and executive management on the operation and progress of compliance efforts and initiatives, audit findings, investigation outcomes, and project status updates.
Assist in compliance investigations involving potential violations of compliance policies, laws or regulations and overseeing corrective action.
Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, state and federal privacy laws including GDPR, fraud and abuse and anti-kickback statutes, OIG guidelines, industry codes in relevant markets including PhRMA, EFPIA and JPMA, US state marketing compliance laws, FCPA, UK Bribery Act and other anti-bribery laws.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's degree required and Law degree preferred.
10 or more years of pharmaceutical company compliance experience.
Proven record of accomplishment in the areas of global compliance best practices.
Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry.
Strong public... For full info follow application link.
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