Seattle, WA · Biotech/Pharmaceutical · $213,200 – $252,350 per year
Our client is a clinical-stage biopharmaceutical company pursuing discovery, development and commercialization of small-molecule and protein therapeutics.
The Senior Counsel, Director of Compliance will be primarily responsible for provision of legal and strategic guidance to functional departments throughout the organization on a broad range of legal and compliance matters related to the company’s branded pharmaceutical products and investigational agents. Reporting to the General Counsel, the role will be responsible for management of compliance programs across the Company’s operations and will lead initiatives to enhance the organization’s compliance auditing and monitoring functions. Position Responsibilities
Provide advice, education, training and legal direction in areas of healthcare regulatory law applicable to manufacturers of branded pharmaceutical products, including applicable rules and regulations of the FDA, OIG and CMS and applicable anti-kickback, privacy, fraud and abuse, anti-corruption and product liability statutes and regulations
Perform enterprise compliance risk assessments together with the VP, General Counsel to identify areas of potential compliance vulnerability and risk and develop and implement action plans for mitigation of compliance risk
Build upon and implement the healthcare compliance internal auditing and monitoring program. Develop auditing and monitoring plans, and work with colleagues to conduct record-based audits and live monitoring
Manage delivery of internal compliance training programs and develop/update training curricula in response to organizational needs and legal developments
Provide strategic and tactical direction to the organization regarding existing and emerging local and global privacy and data protection laws
Develop annual compliance work plans and present regularly to Company leadership within areas of responsibility
Coordinate delivery of compliance-related services by outside vendors and counsel
Work with and at the direction of the VP, General Counsel to support and address the needs of the business as they may arise from time to time
Position Qualifications (education, experience, knowledge, and skills):
J.D. and admission to practice law in at least one state required, with admission in Washington state is preferred
At least seven (7) years of relevant legal and/or healthcare compliance experience
Demonstrated knowledge of legal standards and industry best practices for the operation of effective compliance programs
Experience conducting compliance auditing and monitoring is preferred
Knowledge of Anti-Kickback Statutes, False Claims Acts, Food Drug and Cosmetics Act, FDA rules and guidance, and transparency requirements; knowledge of applicable European laws, regulations and industry guidance is a plus
Knowledge of data privacy law considerations for pharmaceutical manufacturers is preferred
Must display strong analytical and problem-solving skills
Strong English grammar and usage skills, including in verbal and written communications
Facility with basic computer applications used in general office settings, including word processing, spreadsheet, and presentation software; experience with Veeva Vault a plus.
Compensation and Benefits Salary Range: $213,200 – $252,350 per year Our client offers a competitive compensation package. Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. This position is eligible for bonus and stock options.