US Product Counsel - Job ID: 1106

The Product Counsel will be responsible for reviewing promotional nonpromotional and scientific materials and strategies, evaluating strategic and tactical commercial/brand and US medical affairs plans, supporting clinical educator programs, and advising clients on a broad array of issues relating to FDA pharmaceutical regulations, advertising, marketing, product development, product labeling, promotional review, media materials, anti-kickback, competitor issues, regulatory policy, medical, privacy, sales, industry and company issues. The position will be in the Ascendis Pharma, Inc. Princeton, New Jersey office and report to the US General Counsel and Chief Compliance Officer.

Key Responsibilities

• This is a dynamic role giving advice on legal and regulatory issues as they arise from the marketing, sales, and US medical teams
• The Product Counsel will work on cross-functional business teams
• There will be no direct responsibility for contract review, but the individual will be responsible for advising the transactional attorney on regulatory and compliance risks
• Advising on the review of promotional materials and tactics including social media and healthcare professional and consumer-directed advertising as well as nonpromotional/scientific pieces and scientific exchange materials
• Participating in review committee meetings
• Providing legal strategic advice regarding customer and other stakeholder relationships, regulatory matters, contracts, and interactions with respect to branded/specialty pharmaceuticals
• Advising on specific regulatory or compliance risks, and counsels management in connection with related matters
• Partnering with other legal colleagues in executing and enhancing Company objectives
• Working as part of a matrix team
• Assisting in supporting compliance function; helping to create and deliver training to clients
• Ability to forge strong working relationships with employees in different disciplines and at all levels of the organization.
• Demonstrate high standards of conduct and ethics as well as appropriate judgment, independence, and discretion
• Ability to be proactive, exercise judgment and manage multiple responsibilities simultaneously
• Strong organizational skills with the ability to handle and prioritize a high volume of work and independently manage multiple complex projects simultaneously

Requirements

• Juris Doctorate (J.D.) or LLM 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
• A minimum of 5 years of relevant experience. Prior experience as a member of an in-house legal department at a biotechnology or pharmaceuticals company strongly preferred
• Experience with FDA laws and regulations, promotional and nonpromotional review
• 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
• New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law
• Salary range: $230-$260K/year

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance