Associate Director, Legal

Helsinn is a growing, privately owned pharmaceutical group based in Lugano, Switzerland, with U.S. offices in New Jersey. Helsinns success depends on the excellent execution of product and clinical development and commercial operations, as well as on finding new business opportunities. The position of Associate Director - Legal will serve as a dedicated resource to manage HTUs legal matters, in coordination with the Vice President, Legal, and Groups Legal Department at headquarters. The Associate Director - Legal will be responsible for advising HTU and its personnel on U.S. legal and regulatory matters regarding the marketing, sales, distribution, and government pricing for its FDA approved products and will have a responsibility, in coordination with the Vice President - Legal, with managing outside legal resources in the U.S.

MAIN RESPONSIBILITIES

Manages legal matters pertaining to the U.S. organization and works on complex legal problems that impact the success of the companys products and/or future technologies in coordination with HTUs Commercial Team.
Provides a variety of general corporate and legal advice and services to HTU internal clients.
Acts as advisor on legal issues involving the U.S. organizations government and regulatory compliance matters and manages governance documents and relevant filings.
Ensures compliance and implementation by the U.S. organization with Helsinn Group and HTU corporate rules, standard operating procedures, policies and legal templates.
Oversees outside counsel to assist in legal matters as necessary.
Monitors state and federal legislation, analyses requirements, determines business impact and provides advice to affected areas.
Serves as a 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.
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 Marketing, Sales and Medical Departments, providing legal advice on marketing, sales and medical strategies and tactics relating to Helsinn products.
Coordinate with, train, and oversee paralegal and administrative support staff.

WORK EXPERIENCE REQUIREMENTS AND QUALIFICATIONS
Minimum of 5 years of legal experience, either in a law firm or in-house in the pharmaceutical or related industry, is required.
Previous in-house experience with legal support for specialty/branded pharmaceuticals is preferred.
Experience with FDA laws and regulations promotional and nonpromotional review, and guidance provided by the Office of the Inspector General for HHS is required.
Strong interpersonal skills.
Excellent oral and written communication skills; strong presentation skills, with the ability to communicate abstract ideas and legal advice to executive and senior management as well as non-legal colleagues and non-native English speakers.
Excellent critical thinking skills: ability to work through complex issues, including those with significant strategic risk to the company.
Strategic, analytical thinker and creative problem solver who possesses innovation, client management, demand management skills, and regulatory knowledge.
Selfless, promoting team and company objectives over individual accomplishments.
Strong organizational skills with the ability to handle and prioritize a high volume of work and independently manage multiple complex projects simultaneously.
Demonstrated broad understanding of the business environment and capable of anticipating future challenges resulting from change and the ability to adapt quickly and keep up with a fastpaced and highly demanding environment and regulatory framework.
Ability to respond resourcefully and strategically to shifting priorities and work effectively in ambiguous or challenging situations.
Energetic selfstarter with demonstrated influencing skills and a results orientation. Must be able to quickly gain the trust and respect of senior executives, peers, and clients.
Ability to work both in a strategic big picture mode, as well as tactically, including the capability to roll up ones sleeves and work in detail.
Demonstrated client service orientation; able to recognize and respond quickly and pragmatically to urgent situations and demanding clients while setting demand management and expectations for highest-priority matters.
Track record of flexibility and possessing a commercial, business focus in approaching this position.
Ability to travel 10-15%.
MS Office suite proficiency.


EDUCATION REQUIREMENT
Juris Doctorate (J.D.) degree from a nationally recognized law school.
Admitted to the Bar of at least one state and eligible for admission to the New York or New Jersey Bar as in-house counsel.
Employment Type: Full-Time