Description:
Role and Responsibilities:- Counsel internal stakeholders regarding advertising and promotion, external communications, sales and marketing initiatives, FDA and OIG guidance, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals, payors, patients, and/or patient advocacy organizations.
- Independently draft, review, and negotiate commercial contracts to support An American Biotechnology Company's Commercial organization.
- Provide analysis, guidance, training, and support to functions such as Marketing, Sales, Market Access, Patient Advocacy, Medical Affairs, and Corporate Communications engaged in external communications and outreach related to pipeline and/or approved products and related conditions.
- Advise internal stakeholders on potential legal issues and appropriate risk mitigation strategies regarding advertising, promotion, product liability, anti-trust, and relevant healthcare rules and regulations (e.g., fraud and abuse, anti-kickback, and false claims act statutes).
- Work closely with Global Compliance & Ethics Program including counseling and training on compliance policies and healthcare compliance regulations.
- Assist with periodic compliance risk assessments and investigations of alleged violations of corporate policies and procedures, laws, or regulations, and advise on development and implementation of corrective action plans where compliance violations have been established.
- Prepare regular briefing documents to keep Executive Management up to date on latest industry events and trends related to key risk areas including OIG and FDA enforcement, CIA trends, and analysis of OPDP warning and untitled letters.
- Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology companies, along with recent industry trends and changes.
Education:
A JD degree.
Experience:
- 3 - 7 years of experience working in a law firm or the pharmaceutical/healthcare legal/compliance field. Experience in-house, at a regulatory agency, or at a major law firm also welcome.
- Experience with pipeline and marketed brand support and associated statutes, regulations, guidance documents, enforcement trends, and best practices related to the pharmaceutical, biotechnology, and/or healthcare industry generally.
- Experience in drafting, reviewing, and negotiating commercial agreements.
- Experience with the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
- Experience with the legal/compliance framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act.
- Demonstrated effectiveness operating in complex organizational and regulatory environments.
- Excellent written, oral, and presentation skills.
- Proven ability to work with all levels of management and the general workforce, a strong sense of professionalism, and the drive to provide superb and timely support to internal clients.
- Strong problem solving, risk analysis, and project management skills.
- Demonstrated ability to partner effectively with others in addressing complex issues.
- Strong persuasive skills and sound business judgment.
- Motivated, self-starter with ability to appropriately prioritize issues, drive projects, and allocate resources.
