Associate Director / Director Compliance Avanir Pharmaceuticals
THIS JOB HAS EXPIRED POSITION DETAILS
The Associate Director/Director Compliance assists in developing, implementing and maintaining an effective Corporate Compliance Program that:
Supports and promotes a company-wide culture of ethics and compliance;
Ensures the company's compliance with all applicable federal and state health care laws and regulations, and industry codes of conduct; and
This position is primarily responsible for the development and implementation of compliance policies, training programs, communications and audit/monitoring programs. As a member of a collaborative team, this position also will contribute to the development and implementation of other components of the compliance program.
ESSENTIAL JOB FUNCTIONS
Develops, revises, updates and maintains compliance policies, procedures and instructions, and collaborates with other departments of the company in addressing their policies, etc. relating to or impacting the company's healthcare compliance program
Develops and delivers compliance training at company and departmental meetings
Investigates complaints and coordinates action plans with other departments
Partner with key stakeholders across all functional areas including Research & Development and Medical Affairs to address questions and issues, and to implement compliance work plans
Assists the CCO in preparing the annual compliance work plan based upon a comprehensive, annual compliance risk assessment of relevant functional areas of the company
Assists the CCO in preparing reports to the Compliance Committee of the Board of Directors
Assists the CCO in developing and executing the agenda, meetings and responsibilities of the company's Compliance Committee
Possesses and maintains an up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct and developments, and best practices applicable to the company's policies, practices or operations, including but not limited to the 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, PDMA, AMA, and industry guidance documents, regulations regarding the promotion of marketed products, clinical trial regulations, and the False Claims Act and anti-kickback statutes.
Other responsibilities and duties as may be assigned.
The person performing in this position is expected to possess the following qualifications:
Strong ethics and integrity
Ability to work independently with no routine supervision
Demonstrated ability to exercise independent judgment with knowledge of the pharmaceutical industry
Strong interpersonal skills and collaborative ability
Strong analytical skills and demonstrated ability to successfully perform multiple projects in a timely and effective manner
The ability to work under pressure and meet deadlines
Excellent planning, project management and research skills
Ability to analyze data, develop and maintain databases, and generate formal written reports
The ability to communicate, orally and in writing, effectively and persuasively
Track record for successfully working cross-functionally on a wide range of pharmaceutical compliance activities
Experience in creating and implementing training programs including strong speaking skills
Ability to identify problems, explore options and recommend solutions through strong critical thinking, problem solving and decision making skills
Effective at managing, synthesizing and communicating complex information
Demonstrated experience in handling confidential and sensitive situations or information with ability to exercise a high degree of judgment and discretion while maintaining strict confidentiality as required
The ability to travel, approximately 5% of working time.
Bachelors degree required. Advanced degree, e.g. J.D., Masters, PhD, etc., a plus.
Minimum of eight (8) years experience in the pharmaceutical/medical device industry
Minimum of five (5) years experience in pharmaceutical/medical device manufacturing health care compliance programs
||101 Enterprise |
Aliso Viejo, CA 92656
THIS JOB HAS EXPIRED