Our client is seeking to hire an exceptional Senior Corporate Counsel, reporting to the SVP & General Counsel, to be responsible for providing advice and counsel to key client groups regarding the Company’s proposed commercialization and regulatory compliance activities. This individual will ensure effective influence on executive and line management regarding the myriad statutes and regulations applicable to the commercial sales and marketing of drug products including applicable healthcare and privacy statutes.

An important aspect of this position will be to assist the Company’s SVP & General Counsel and functional client groups in designing, implementing and monitoring up-to-date compliance programs and governance structures to meet the Company’s commercial goals with appropriate legal and business oversight. The Senior Corporate Counsel will play an important leadership role and provide a key center of expertise in the organization. The successful candidate must be able a self-starter comfortable with significant responsibility and be able to interact effectively and influence peers, employees and all levels of management.

General Summary:

·         Provides day-to-day advice regarding a wide range of activities and programs related to drug product development and commercialization.

·         Provides day-to-day counsel in designing, implementing and monitoring the Company’s commercial compliance programs and policies in connection with marketing and sales of its products, including some specific programs highlighted below.

·         Helps to develop/implement/monitor the strategies and materials for the training and deployment of the Company’s Medical Science Liaison program and field sales personnel.

·         Provides advice and counsel regarding continuing medical education activities, structuring of advisory panels and speakers’ bureaus, among other initiatives.

·         Provides advice and counsel on various sales and marketing and other materials for dissemination relating to the Company and its potential products and disease areas, as well as review of product labeling and liability questions.

·         Supports day-to-day contract needs of the marketing, sales and medical affairs functions, including managed care contracting, distributor arrangements, grants, advisory board and speaker bureau contracts.

·         Takes a leadership role in the establishment and maintenance of a corporate compliance program.

Requirements:

·         JD degree, as well as membership in good standing of at least one state bar.

·         Typically 8+ years of related legal experience, with at least three years in-house experience providing advice and counsel to a biopharmaceutical or pharmaceutical organization.

·         A solid working knowledge of biopharmaceutical marketing and sales programs and of the application to these activities of the various statutes, regulations and guidance documents applicable to these activities will be essential (e.g., the Food, Drug and Cosmetic Act, regulations and guidance documents; the federal and state anti-kickback statutes, regulations and OIG guidance documents and opinions; the federal False Claims Act; the Prescription Drug Marketing Act and regulations; HIPPA; and ACCME policies and guidelines).

·         Experience working within existing compliance structures at biopharmaceutical companies is essential. Experience with creating and negotiating managed care contracts is a plus.

·         Demonstrated ability to create, review and work with a wide range of materials, including compliance policies, training materials, product labeling, grant proposals, and proposed promotional materials.

·         Good general working knowledge of liability issues and contract preparation and negotiation.

·         Strong written and verbal communications skills, including the ability to communicate concisely to clients, to integrate legal and business knowledge and to provide balanced advice regarding risks.
The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.