Main Responsibilities:
Manages all legal matterspertaining totheU.S.organization, andworks on complex legal problems thatimpactthe success of the company's products and/or future technologies in coordination withHelsinnGroup 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 theU.S.organization's government and regulatory compliance matters and manages governance documents and relevant filings.
Ensures compliance and implementation by the U.S. organization withHelsinnGroup corporate rules, standard operating procedures,policiesand legal templates.
Retains and oversees outside counsel toassistin significant matters in coordination withHelsinnGroup Legal.
Monitorsstate and federal legislation,analyzesrequirements,determinesbusinessimpactand providesadvice to affected areas.
Supportsthe activities ofHelsinnGroup Legalwith regard tolegal matters in the IP area (patents, trademarks), new Business Development opportunities, and global projects.
Servesas the legal representative to thePromotional Review Committee (PRC)to review promotional and sales training/support materials; attends weekly PRC meeting.
Keepscurrent 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 ongoingsales,distribution, and pricingof the company's products, licenseagreements, CDAs,in accordance withtheHelsinnGroup templates, employment law matters, immigration law matters, regulatory matters and FDA responses.
Advises on matters involving marketed drugs, trade secrets, advertising law,registrationand other issues specific to the life science industry and on general corporate governance matters.
Works closely with theCommercial organization, specifically with theSenior DirectorContracting & Pricing and the ExecutiveDirector Market Access, toadviseon the sales, distribution, and pricing of U.S. products.
Work Experience:
15years of legal experience, with 8 years or morewithinthe pharmaceutical or biotech industry in positions of increasing responsibility supporting the Commercial organization.
Abilityto work in an international environment,withexperience in a multinational corporation preferred.
Ability to travel 10-15%.
Strong interpersonal,writtenand verbal communication skills.
MS Office suiteproficiency.
Education:
JD Degree required