Role & Function Introduction/PurposeThe Head of Legal and Compliance oversees both the legal and Compliance activities in Sobi Inc. North America. This person is responsible for ensuring that a culture of compliance is maintained by all employees, directors and Vice Presidents of the company. The Head of legal and compliance partners with the business to develop practical ways to uphold the legal, regulatory, and ethical obligations of a pharmaceutical manufacturer in North America. This position sits on the North America and Legal leadership teams, is an important member of cross functional initiatives and committees. The Head of legal and compliance is also responsible for communicating regularly with corp., the General Counsel and the President of Sobi Inc. North America.
Primary counsel to the NA organization and to Sobi AB for North American related matter
Company legal representative
Sits on the North America Leadership team (NALT), Legal Leadership team (LLT) and Pricing and Incentive Compensation committees.
Ensure all TA media, promotional materials and activities comply with law, regulations, industry guidance and company policies including Anti-Kick back statue, false claims Act and foreign corrupt practices Act.
Develop and implement legal policies.
Developing, implementing and participating in training and ensuring appropriate training specifically geared towards the business function which incorporates critical policies and procedures, as well as applicable industry laws, rules, regulations and guidance.
Advise North American and global commercial teams regarding life-cycle management initiatives and launch preparations for investigational products in the US.
Draft and negotiate various agreements, to include commercial, distribution, supply chain, manages markets, advertising, licensing, collaboration, grant, sponsored research, clinical trial agreements, speaker, consultant and Business Deve
Interpersonal Skills• Excellent grammar, communication and interpersonal skills.• Clear, concise and persuasive writing and presentation skills.• Demonstrated ability to work effectively and collaboratively with employees at different levels.• Able to operate successfully in a constantly changing, fast-paced environment.• Demonstrated initiative, self-motivation, practical learning skills, enthusiasm, and an ability to complete multiple tasks in a timely and accurate manner.• Strong problem solving skills.• Demonstrated ability to partner effectively with others in handling complex issues.• Strong influencing skills and sound business judgment.• Decisive and exercises good judgment under pressure.• Ability to manage a diverse and demanding workload.
Significant experience in the health care industry, with specific experience in ethics, compliance or legal. Twelve (12) to fifteen (15) years of direct experience preferred.
Demonstrated knowledge of legal and compliance standards as outlined by the Office of Inspectors General and furthered by enforcement actions and industry best practices.
Knowledge of Anti-Kickback Statutes, False Claims Acts, Food Drug and Cosmetics Act, FDA rules, and transparency requirements
Working knowledge of transparency requirements including federal and state sample reporting, transfer of value disclosure and aggregate spend
Working knowledge of pricing and reimbursement requirements in North American markets
Knowledge and experience reviewing promotional materials
Extensive knowledge of requirements guiding interactions with HCPs, HCOs, the government, payers, and patients
Experience with privacy considerations for pharmaceutical manufacturers preferred.