Director - Commercial Compliance - Depomed - San Francisco

Job description
This position will have a leadership role in Legal and Compliance at Depomed and will report to the Compliance Officer. This position is responsible for the development and maintenance of compliance policies as well as training, monitoring, auditing and reporting to ensure compliance with applicable laws and regulations and Depomed policies and procedures
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 Marketing, Sales and Medical Affairs to address questions and issues, and to implement compliance work plans

Lead for corporate-wide aggregate spend program
Ensure accuracy of all HCP transfer of value spend data gathered from internal and external source data systems.
Project Manage & Assist on all business support projects related to aggregate spend and transparency reporting requirements.
Support and prepare the required federal and state payment reports including verifications and review of data.
Assists the CO in preparing the annual compliance work plan based upon a comprehensive, annual compliance risk assessment of relevant functional areas of the company
Assists the CO 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.

Desired Skills and Experience
EDUCATION and EXPERIENCE
Bachelor 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
ADDITIONAL RESPONSIBILTIES/DUTIES:
Strong ethics and integrity
Ability to work independently without 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
Track record for successfully working cross-functionally on a wide range of pharmaceutical compliance activities
The ability to communicate, orally and in writing, effectively and persuasively
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 20-25% of working time.
KEY COMPETENCIES INCLUDE:
Integrity
Decisions & Judgment
Ownership & Initiative
Adaptability & Change Readiness
Teamwork & Collaboration

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