Compliance Director, Pharmaceuticals

Pharmaceutical company seeks Compliance Director. The successful candidate will have a strong knowledge of PhRMA Code, FDA, and OIG standards governing the sales and marketing of pharmaceuticals. Only candidates with pharmaceutical or medical device compliance experience (in-house, law firm, consulting firm and/or government agency) will be considered.

PRIMARY JOB FUNCTION:

• Provides direct oversight for complex elements of the company’s compliance program at the franchise, business unit, regional, divisional or corporate level.
• Responsible for directing the development and administration of Office of Ethics and Compliance education and training, and development and implementation of divisional monitoring plan, identifying compliance risk areas and communicates such risk areas to division management along with action plans to address risk.

CORE JOB RESPONSIBILITIES:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• The Director performs the following with minimal supervision from Ethics and Compliance Officer: Provide leadership, guidance and support to all levels of key divisional business functions on complex ethics and compliance issues, including policy interpretation and requirement, compliance risk assessment, trend analysis and best practice recommendations. Resolves complex ethics and compliance matters that have significant impact to the company.
• Directs and conducts periodic reviews and updates related to complex Office of Ethics and Compliance policy and divisional/affiliate procedures ensuring clarity, applicability and compliance to OEC policy and external requirements with minimal supervision from Ethics and Compliance Officer.
• Develops, updates, implements, and delivers Office of Ethics and Compliance’s comprehensive training program on complex Office of Ethics and Compliance and divisional/affiliate policies and procedures.
• Provides oversight to corporate and/or divisional monitoring process to ensure compliance with OEC/affiliate policies and procedures. Reviews industry trends and internal results, and recommends corrective actions.
• Partners with Ethics Compliance Officer and business on compliance audits, oversees the fulfillment of auditors requests, acts as liaison between business and auditors during on-site activities, evaluates and responds to all complex preliminary findings and recommendations, guides the business in preparing corrective action to address complex and highly complex findings and recommendations.
• Oversees all Compliance Review Committees at the divisional or affiliate level and provides input on violation process. Reviews internal trends and implements corrective actions.
• Provides leadership and guidance on proposed commercial programs, identifies complex legal and regulatory issues, analyzes alternatives and works with legal, as appropriate, to propose solutions to the business.
• Possesses in-depth knowledge of the company’s businesses supported and knowledge of the broader business impact.
• Leads cross-functional teams on complex issues or projects.

POSITION ACCOUNTABILITY / SCOPE:

• Accountable to Ethics and Compliance Officer and senior divisional management.
• Assigned matters/business units have significant impact on the company’s compliance program.
• Operates with autonomy and limited supervision.
• Provides guidance and direction to Coordinators, Compliance Analysts, Compliance Managers as needed.

Requirements:

Minimum of 8 years experience with, or exposure to, business functions such as compliance, legal, regulatory affairs, government affairs, and finance.

BA/BS required. CPA, Masters, JD, or equivalent work experience strongly preferred.