Manages all legal matters pertaining to the U.S.organization, and works on complex legal problems that impact the success of the company’s products and/or future technologies in coordination with Helsinn Group Legal.
Provides a variety of general corporate and legal advice and services to HTU management and other internal clients.
Acts as advisor on legal issues involving the U.S. organization’s government and regulatory compliance matters and manages governance documents and relevant filings.
Ensures compliance and implementation by the U.S. organization with Helsinn Group corporate rules, standard operating procedures, policies and legal templates.
Retains and oversees outside counsel to assist in significant matters in coordination with Helsinn Group Legal.
Monitors state and federal legislation, analyzes requirements, determines business impact and provides advice to affected areas.
Supports the activities of Helsinn Group Legal with regard to legal matters in the IP area (patents, trademarks), new Business Development opportunities, and global projects.
Serves as the legal representative to the Promotional Review Committee (PRC) to review promotional and sales training/support materials; attends weekly PRC meeting.
Keeps current on relevant legislative issues, statutes, decisions, and regulations of the FDA and other regulatory bodies.
Manages general corporate matters including the drafting, review and negotiation of contracts related to the ongoing sales, distribution, and pricing of the company’s products, license agreements, CDAs, in accordance with the Helsinn Group templates, employment law matters, immigration law matters, regulatory matters and FDA responses.
Advises on matters involving marketed drugs, trade secrets, advertising law, registration and other issues specific to the life science industry and on general corporate governance matters.
Works closely with the Commercial organization, specifically with the Senior Director Contracting & Pricing and the Executive Director Market Access, to advise on the sales, distribution, and pricing of U.S. products.
Work Experience:
15 years of legal experience, with 8 years or more within the pharmaceutical or biotech industry in positions of increasing responsibility supporting the Commercial organization.
Ability to work in an international environment, with experience in a multinational corporation preferred.
Ability to travel 10-15%.
Strong interpersonal, written and verbal communication skills.
