Description
Job Description

Job Summary
This position is responsible for leading the implementation of effective compliance program operations that support one or more of the Company's commercial lines of business and managing a team of compliance professionals and/or support personnel devoted to the execution and oversight of the program.

Job Responsibilities

• Lead a compliance team responsible for the implementation and oversight of day to day compliance program operations for one or more of the Company's commercial lines of business, including Company and individual client-based policies, procedures and ethical standards (e.g., based on specific OIG Corporate Integrity Agreement requirements applicable to the client), training and education, compliance monitoring mechanisms, and providing ongoing compliance operational support to clients and internal commercial business stakeholders. Provides input for operating strategy, policies and procedures for subordinates and decisions are likely to impact multiple areas and/or client accounts.
• Support the creation, maintenance and/or implementation of company commercial business and client-specific compliance policies, rules and standard operating procedures to ensure operational compliance by company employees with the following pharmaceutical industry legal, regulatory compliance requirements and ethical standards (as applicable) that govern the sale or promotion of pharmaceuticals or medical devices and interactions with health care providers and patients.
• Provide guidance to internal business stakeholders on applicable commercial compliance requirements to commercial lines of business, including product or device promotional requirements and associated communications, sample management activities, speaker bureaus, incentive plans, fraud, waste and abuse requirements (off label promotion, anti-kickback requirements), etc.
• Ensure company employees conduct business on behalf of commercial clients in a manner that is consistent with the Company's Code of Business Conduct and Ethics and other applicable corporate compliance and ethics program policies and procedures, including any applicable client corporate compliance or ethics rules.
• Collaborate with and provide support to business development and commercial business leadership to launch new client lines of business or existing client additional lines of commercial business, including adapting existing commercial compliance policies, procedures, training and educational requirements and operational compliance oversight mechanisms as necessary to support the particular launch.
• Ensure the effective and strategic use of available databases, systems (e.g., Veeva, Concur), data, and metrics to conduct effective oversight of applicable commercial compliance operations and determine the effectiveness of existing controls and promote enhancements of these data and systems, as appropriate, for improved commercial compliance strategic and operational support.
• Collaborate with and provide support to internal stakeholders (Corporate Compliance, Human Resources, commercial compliance business management) and clients, as appropriate, when instances of non-compliance with commercial compliance company or client requirements are detected, including in the investigations process to ensure prompt, effective action is taken to determine the nature and extent of the non-compliance, identity root cause and institute effective individual disciplinary action or programmatic changes, as applicable.
• Provide day to day guidance to commercial business leadership and teams related to Code of Business Conduct and Ethics and other applicable corporate compliance policies and procedures, on an as needed basis, that is consistent with these requirements. Collaborate with corporate compliance colleagues to ensure the company's Code of Conduct and Business Ethics and corporate compliance and ethics program policies and operating standards are being complied with and enforced consistently, including identifying instances of non-compliance, escalating identified concerns to corporate compliance colleagues to ensure instances of non-compliance are promptly reported, investigated and resolved in accordance with applicable corporate compliance and ethics program requirements and standard operating procedures.
• Support development of applicable risk management tools and ongoing monitoring to support prompt and effective identification of commercial compliance risks, identification of programmatic gaps and implementation of corrective actions.
• Support client audits, prepare and implement corrective action plans as needed and collaborate with commercial quality internal colleagues.
• Provide compliance governance support, as needed, to various governance bodies, including the Compliance Committee and the Commercial Quality Council.
• Act as a compliance and ethics role model and ambassador to create awareness and promote compliance with the Company's Code of Conduct and Business Ethics and other corporate compliance policies (e.g., conflicts of interest, gifts and entertainment, anti-bribery/anti-corruption policy).

Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation.

Qualification Requirements
Bachelor's Degree, preferred, in a healthcare related field and relevant work experience in a compliance role with a company, preferably in the healthcare (bio/pharma/med device) industry. Fluent Janese and English (written and spoken)

Experience with:

• Broad-based compliance program support
• Implementation of compliance training programs; experience with learning systems
• Business process improvements/project management
• Compliance-related databases
• Interaction with regulators/agencies
• Interaction with clients; strong customer relations skills a must
• Interaction with upper management
• Investigations; development and implementation of corrective actions