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Chief Compliance Officer

Irvine, CA, USA | Leading Pharmaceutical / Biotech Company

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
    Legal / Compliance
  • Experience:
    15-20 years
Job Description:
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The Chief Compliance Officer (CCO) will report to the General Counsel and will provide structure, oversight and guidance for the global Compliance and Data Privacy functions of the company.The CCO will be a member of the Legal Department and act as a strategic business partner and subject matter expert in compliance and will keep the company and its policies and practices up to date with the laws, rules and regulations governing the pharmaceutical industry today. The position manages a team of three compliance/audit/transparency professionals.



Essential Duties & Responsibilities:

 Primary Responsibilities  

Define and develop the annual compliance work plan for an organization that is growing internationally. Areas of focus include healthcare professional spend transparency, international and domestic privacy and data protection, and compliance with pharmaceutical regulations and other applicable laws.

Create a cross-functional corporate training program based on compliance requirements for each department to improve understanding of related laws and regulatory requirements.

Work with the legal team to develop and implement an internal audit, investigations and monitoring function. Coordinate the development and implementation of corrective actions as required.

Work with and at the direction of the General Counsel to support and address the Legal and Compliance needs of the business as they may arise from time to time. Coordinate with other attorneys on delivery of services.

Oversee the transparency reporting function including further build out of the global reporting function as well as manage and report Open Payments and state related transparency reporting.

Partner with commercial operations to create master data tables, data marts, dash boards and other tools to facilitate the operationalization of the compliance function.

 Monitor the performance of the Compliance Program and related activities on a continuing basis, taking appropriate steps to improve its effectiveness.

Provide strategic direction to the organization regarding existing and emerging local and global privacy and data protection laws.

Develop, initiate, maintain, and revise policies and procedures for the general operation of the compliance program and its related activities to prevent illegal, unethical, or improper conduct. Partner with HR, Finance and other departments where appropriate.

• Develop and periodically review and update Code of Conduct to ensure continuing relevance in providing guidance to management and employees.

• Perform Risk Assessments to identify areas of potential compliance vulnerability and risk, develop and implement corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future.

• Chair the Compliance Committee and be responsible for its oversight and operation.

• Ensure proper triage and handling of violations or potential violations internally and ensure the reporting of such violations to duly authorized enforcement agencies as appropriate or required.

• Institute and maintain an effective compliance communication program for the organization, including promoting: (a) use of the compliance hotline; (b) heightened awareness of Code of Conduct, and (c) understanding of new and existing compliance issues and related policies and procedures.



Competencies:

To perform the job successfully, an individual should demonstrate the following competencies to perform the essential functions of this position.

Dedication—the individual should be committed to achieving results under demanding time frames.

Analytical—the individual must be adept at synthesizing complex information or diverse fact patterns.

Problem solving—the individual must be able to identify and resolve problems in a timely manner and gather and analyze information skillfully.

Oral communication—the individual must speak clearly and persuasively in positive or negative situations and be skilled in making group presentations and conducting meetings. 

Leadership—the individual should be able to inspire and motivate others to perform well and accept feedback from others.

Management skills—the individual should have experience managing a staff of professionals and interacting with corporate executives.

Quality management—the individual should look for ways to improve and promote quality and demonstrate accuracy and thoroughness.

Judgment—the individual must be willing to make and be accountable for decisions, exhibit sound and accurate judgment and make execute within a corporate hierarchy.

Planning/organizing—the individual should be adept at prioritizing and planning work activities, use time efficiently and develop realistic action plans.

Integrity—the individual must possess high ethical standards and expect the same from all others in the organization



Qualification Requirements:

 Education & Experience

Required: Law Degree. Fifteen years’ experience in compliance or equivalent, preferably in the area of pharmaceuticals, medical device or biologics.

Broad legal skills and experience beyond compliance. Commercial or litigation legal experience a plus.

Ability to communicate effectively throughout the organization and with outside vendors. 

Ability and willingness to travel domestically and internationally as needed


 


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