VP, Assistant General Counsel – Regulatory and Commercial
The VP, Assistant General Counsel – Regulatory and Commercial, reporting to the EVP & Chief Legal Officer is a member of the Legal Leadership team with primary responsibility for providing strategic and practical legal counsel to Endo’s Branded Pharmaceuticals Commercial, Compliance and Research and Development organizations on a wide variety of highly complex business and regulatory issues with important legal implications pertinent to the organization. The successful candidate will provide strategic management consultation to Senior Management throughout the organization and oversight of the Branded Pharmaceuticals legal team.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority – span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Regulatory, Compliance and Commercial – primarily domestic; excludes patent counsel
Key Accountabilities – key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Strategic Legal Support for the Commercial and Regulatory Teams
§ Serve as a recognized thought leader within in the legal-regulatory, legal-compliance and legal-commercial areas. Coordinate strategy at a high level to help ensure goals are met.
§ Advise senior management concerning legal-regulatory, legal-compliance (including privacy) and legal-commercial matters that have widespread impact.
§ Responsible for regulatory counsel activities, including, but not limited to, interactions with:
o U.S. Food and Drug Administration (FDA)
o Drug Enforcement Agency (DEA)
o State and federal healthcare agencies
o Other governmental authorities
§ This role would oversee and direct a small team of legal professionals who have a primary responsibility for providing advice and support to Endo’s Branded Pharmaceuticals Commercial and R&D functions on US-wide regulatory contracts and issues.
§ Works closely with Branded Pharmaceuticals business unit, R&D, Government Affairs, Regulatory Affairs, Corporate Compliance and with various leadership teams on issues of regulatory policy, including FDA reform legislation, data exclusivity issues, labeling issues, and other compliance matters.
§ Responsible for providing legal advice, counsel and services that ensure the organization is operating in compliance with regulations and that regulatory reporting requirements are met.
§ Give strategic advice to Regulatory Affairs, Commercial and Medical Affairs on FDCA issues, including drug submission issues, advertising and promotion issues, lifecycle planning issues, REMS issues, HCP interactions and evolving law.
§ Represents the Company on various industry trade association and intra-industry legal initiatives focused on regulatory issues.
§ Oversees support on contracting, strategic initiatives and other issues that Commercial, Medical, Compliance and Regulatory Affairs undertake.
§ Provides counsel for the life-cycle management of Endo products including compound development, NDA submission, commercialization plans, launch, sale and marketing of company products. As necessary, this includes being the point person for engagement with counterparts at alliance partners in conjunction with commercial and R&D leadership.
§ Creatively resolves complex legal issues in a manner that fosters the Company’s business interests and advances Company’s goals.
Business Unit Support
§ Oversight of the applicable legal team, providing timely and effective legal and risk guidance across the commercial lifecycle of the company’s products.
§ Ensuring functional excellence by identifying and implementing best practices and enhancing systems and workload distribution that allows for business flexibility, launch support and cross-functional development.
§ Provide legal review and strategic oversight of advertising and promotional materials, disease awareness materials, training materials, speakers bureau programs, regulatory submissions, medical education initiatives, advisory board proposals, market research materials, grants, and sponsorships, etc.
§ Hiring, leading, and developing the applicable legal team, managing the day-to-day operations, including budgeting, resource allocation, and recruitment and retention of legal talent.
· Provides Due Diligence Support to Branded Business Unit business development teams.
Manage Outside Counsel
§ Manages outside counsel effectively and efficiently, and consistent with applicable budgets. Works creatively with outside counsel to minimize fees and costs.
Collaboration and Knowledge Sharing
§ Work collaboratively with other business units and functions, and other members of the department in support of business development and alliance management activities.
§ Collaborate with external counsel and internal corporate compliance function on government investigations and compliance matters.
§ Maintain awareness of relevant laws and regulations, keeping abreast of current changes that may affect the organization and inform company of relevant laws and updates.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ JD degree from an ABA accredited law school and admission to a state bar is required.
§ Minimum 15 years legal experience including
§ 10+ years as a “corporate” practitioner
§ At least 5 years prior experience advising on complex FDA regulatory matters, pharmaceutical sales and marketing laws, rules and industry codes.
§ Prior in-house pharmaceutical experience managing a team is required.
§ Experience with ‘C-level’ executives, and advising executives, partnering with heads of businesses, and working with sophisticated leaders is strongly preferred.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Strong knowledge of US pharmaceutical regulatory submission process, promotional, advertising, and labeling requirements, Federal and state healthcare compliance considerations, including the False Claims Act, the Anti-Kickback Statute, the Transparency Provisions of the Patient Protection and Affordable Care Act (the “Sunshine Act”), and US Federal healthcare program requirements under the Food, Drug and Cosmetic Act (“FDCA”).
§ Advanced contract terms and conditions.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Strong leadership presence
§ Capable of thriving in a fast-paced, lean and dynamic legal team
§ Excellent oral, written, negotiating, and communication skills
§ Superior analytical and risk assessment skills
§ Proactive, practical, resourceful, and adaptable
§ Business Acumen.
§ Collaboration skills.
§ Conflict Management skills.
§ Integrity and trust.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Requires a moderate degree of travel
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Learn more here
Job posted: 2020-05-21