Senior Compliance Counsel, R&D
Otsuka Pharmaceutical

Job Info

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Job Summary

Otsuka America Pharmaceutical, Inc. (Otsuka) is looking for a Senior Compliance Counsel, R&D to join its Ethics & Compliance (E&C) Department. Otsuka seeks highly motivated business professionals who are ready to defy limitation, so that others can, too.

The Senior Compliance Counsel, R&D will report to the Vice President & US Chief Compliance Officer and serve as the primary liaison between E&C and Otsuka's R&D business. The Senior Compliance Counsel, R&D will provide real-time advice and guidance to R&D colleagues and work collaboratively with cross-functional partners to support the business. This position may either be based in our Rockville, MD office or our Princeton, NJ office.

Job Description

The Senior Compliance Counsel, R&D will be responsible for providing risk mitigation and corporate compliance guidance to Otsuka's R&D functions, including but not limited to:

• Medical Affairs
• Regulatory Affairs
• Health Economics and Outcomes Research / Real-World Evidence
• Data and Analytics
• Clinical Management
• Clinical Development
• Clinical Programming
• Pharmacovigilance
• Quality
• Tech Ops

The Senior Compliance Counsel, R&D will also provide risk mitigation and corporate compliance guidance to Otsuka's Digital business.

In addition, the Senior Compliance Counsel, R&D will supervise the Associate Director, Corporate Compliance, who serves as operational lead for Otsuka's Clinical Transparency function. In this supervisory role, the Senior Compliance Counsel, R&D will ensure that Clinical Transparency is effectively:

• developing, updating, and training on clinical transparency-related policies and procedures
• overseeing and managing clinical trial results disclosure activities (excluding development and dissemination of lay results summaries)
• supporting Regulatory Affairs in complying with the European Medicines Agency (EMA) Policy 0070.

Along with these core responsibilities, the Senior Compliance Counsel, R&D will provide regular functional updates to the Vice President & US Chief Compliance Officer and, where appropriate, other members of the Executive Leadership Team.

Travel is expected approximately 15% of the time.

Qualifications

Required

• J.D. from an accredited US law school.
• Licensed to practice law in at least one US jurisdiction.
• Minimum of 7 years of combined relevant experience as: (1) an in-house attorney at a pharmaceutical or medical device company, (2) regulatory counsel at FDA, and/or (3) a law firm attorney in a life sciences or healthcare regulatory practice.
• In-depth understanding of the FDA regulatory approval process for pharmaceutical products.
• In-depth understanding of the pharmaceutical product lifecycle.
• Familiarity with FDA regulatory framework for digital therapeutics, including for example, prescription drug-use-related software (PDURS).
• Familiarity with DOJ and OIG guidance regarding effective corporate compliance programs.
• Familiarity with the relevant legal and regulatory landscape, including, but not limited to fraud and abuse laws, (Anti-Kickback Statute, False Claims Act), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), anti-corruption (Foreign Corrupt Practices Act), financial transparency (Physician Payments Sunshine Act), and clinical transparency (EMA Policy 0070).
• Familiarity with relevant industry codes, including the PhRMA Code.

Preferred

• Prior professional experience managing direct reports.
• Strong interpersonal skills.
• Advanced legal research and writing skills.

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Statement Regarding Job Recruiting Fraud Scams

Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.

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