United Therapeutics Corporate Counsel/Senior Corporate Counsel - Regulatory and Compliance in Durham, North Carolina
The Job Details are as follows:
What we do
United Therapeutics is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.
How you’ll contribute
Provide legal support to Sales and Marketing, Commercial Operations, Managed Markets, Medical Affairs, and Compliance groups regarding a broad range of legal, regulatory and compliance issues.
Provide legal counsel on regulatory and compliance issues, with emphasis on FDA regulations, fraud and abuse, and market access
Participate in Promotional Review Committee
Perform legal review of sales training, medical affairs and other company materials
Perform needs assessment related to HCP business engagements
Participate on Grants Review Committee and Investigator Sponsored Study Committee
Assist Corporate Compliance department with drafting and revising policies and procedures
Provide content review of Corporate Compliance training materials
Collaborate and interface with outside counsel, regulatory authorities, and vendors as needed
Oversee project-related budgets as needed
Perform other duties as assigned
For this role you will need
Membership with relevant state bar
6+ years of related experience; 3+ years of which has been as in-house counsel at a pharmaceutical or biotech company
Excellent and effective written and oral communication skills with the ability to counsel and influence business partners
Strong working knowledge of FDA regulations
Strong working knowledge and command of relevant legal subject matter, including Anti-Kickback Statue, False Claims Act, government pricing, market access, and privacy laws
Ability to work independently and as an active team member
Proficient with Microsoft Office
Ability to travel up to 20% as needed
Excellent time management and organizational skills with strong attention to detail and accuracy
Ability to effectively and wisely counsel and influence on risk mitigation
Life as a Unitherian
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our Company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level of job performance and provides state of the art facilities to flourish. This is what makes United Therapeutics a stimulating place to work.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
United Therapeutics currently has five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation, and achievement into success.