Associate Director, Commercial Compliance
Ferring Pharmaceuticals, Inc. - Parsippany, NJ

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Ferring Pharmaceuticals is a private, research-driven specialty biopharmaceutical company active in global markets. The company identifies, develops and markets innovative products in the fields of endocrinology, gastroenterology, infertility, obstetrics, urology and osteoarthritis. In recent years Ferring has expanded beyond its traditional European base, with over 4,500 employees worldwide, it operates subsidiaries in over 50 countries and makes its products available in more than 90 countries.

Scope:

Serve as the Compliance Officer for the Commercial Business Units within FPI. Provide guidance and leadership in compliance related matters to the sales and marketing organization(s). Work independently across FHI groups to establish a strategic compliance training program and curriculum that meets all Federal, State and Local requirements. Design, develop and implement a communication plan for the overall compliance department. Work on the redesign of the Ferring Compliance website. Design, develop and oversee a credentialing process for Hospital and Office based representatives. Partner with HR to develop a systematic process to ensure all hires complete the required HCP federal & state debarment lists and that they are reviewed timely and on an annual basis. Serve as the Legal, Medical and Regulatory committees key compliance liaison. Act as the compliance lead with all brand planning; from concept to field implementation. Work closely with the sales training department to establish training requirements and field clearance certifications via a Learning Management System. Serve as the key compliance investigator for issues that are raised (or observed) as it relates to potential violations. Provides independent direct counsel to sales and marketing on compliance related matters. Position will develop a Compliance hotline and awareness campaign.
A ssists the Chief Compliance Officer in the development, implementation and management of the company’s compliance program for compliance with applicable laws and regulations in a manner consistent with best practices and applicable law and guidance.

Duties:

Work on establishing and inserting compliance requirements into all aspects of field sales and marketing activities.

Establish a training plan and curriculum to address compliance related activities. Oversee all compliance training activities and materials. Address training requirements, records and retention. Provides guidance on materials being developed for use when an HCP is involved, for any type interaction or venue.

Provide guidance to Ferring employees on Compliance issues; focusing on FDA regulatory laws and rules, federal and state transparency rules, and anti-kickback laws, based on best practices in the industry, as needed.

Develop, design and implement a compliance communications plan; plan to include Website, Compliance Connection, Federal & State Regulatory updates, etc.

Develop, design and implement a compliance hotline and escalation process.

Assist CCO on designing and implementing systems and work plans required for Regulatory compliance.

Involvement in the development of the overall compliance strategic plan for FHI. Assist with identifying key risk areas and working to establish the appropriate mitigation plans.

Collaborate with other departments, including Legal, Regulatory, Sales, Sales Operations and Marketing. Identify and manage outside vendors as needed.

Assist CCO in development of annual Compliance Plan, as needed.

Communicate to Ferring employees’ major compliance events, e.g., settlements and laws.

Requirements:

8+ years of experience of working in or for the pharmaceutical industry. Knowledge of Patient Protection Affordable Care Act (PPACA) – Sunshine Act; Federal Food, Drug, Cosmetic Act; Anti-Kickback Statute; and federal and state transparency and disclosure laws. Current knowledge of ongoing compliance federal and state enforcement activities .

Knowledge and understanding of pharmaceutical compliance issues.

Experience involving the implementation of compliance programs and understanding of US pharmaceutical and other regulations. Strong communication (oral and written) skills.

Ferring Pharmaceuticals, Inc. - 16 months ago - save job - block
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