Director & Sr. Counsel II - Pharmaceutical Patient Support & Regulatory Law

Description

Lead legal support for patient support and access, including supporting business teams providing reimbursement, education and other support to patients. The Director  & Sr. Counsel provides a broad range of legal services, typically to Clients at the VP level who control business activities and below.  Level of counseling provided requires broader understanding of the impact decisions may have on the overall business. You will play a pivotal role supporting Boehringer Ingelheim’s U.S. Human Pharmaceutical Business, particularly our Patient Excellence and Therapeutic Areas.  Duties include provision of legal counsel in key areas of patient support and access, and drafting of legal documents.  Should have acquired knowledge of law in at least two (2) specialized areas of pharmaceutical law, one of which must be FDA Regulatory (e.g., patient support programs, market access, patient assistance support) critical to maintaining business operations and be very knowledgeable about the products, competitors and regulatory environment of the company’s businesses.  Mentors more junior attorneys in areas of expertise.
 
In this role as Director / Senior Counsel you will be a part of the team to support our Human Pharma franchise working with our Business Teams in various areas of the HP Business.  As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the company’s success.

We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

This role is based in our  Ridgefield, CT office. 

Compensation Data

This position offers a base salary typically between $228,000 and $350,000.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here. 

Duties & Responsibilities

•    Collaborate with various areas throughout the organization, including patient and internal product and asset teams, as well as other business partners regarding communications, marketing, and promotional activities in compliance with applicable laws and regulations.
Provide day-to-day advice on patient support strategy and engagements.
•    Counsel on day-to-day activities such as support programs, copays, coupons, gift cards, email marketing, text message marketing, charitable marketing, advertising copy review, claim substantiation, and privacy compliance.
•    Assist with investigations and resolutions of compliance issues, including responding to challenges from competitors, governmental agencies, or other self-regulatory authorities regarding product claims, comparative advertising,  and other regulatory related matters.
•    Prepares complex legal documents, including letters, notices, legal opinions, contracts, and corporate documents, etc.  Often supervises more junior attorneys in the drafting of such documents.
•    Influences clients by identifying and communicating to clients risks associated with complex business activities within lawyer's broad understanding of several specialized legal areas; helps identify risks in areas outside lawyer's specialized legal area and provides value-added corporate law insight to evaluate risks effectively; provides training and business advice to clients on applicable legal issues within lawyer’s broad legal expertise.
•    Partners with clients by considering immediate business/legal issues in a broader business context and identifying broader business purposes and objectives; proactively applies broad legal expertise to address both the specific business activity and influence the broader business purposes and objectives; developing alternative fact hypotheticals and legal solutions to clarify options and enable the achievement of successful business outcomes.
•     Confers with other in-house and outside counsel where appropriate.  Also advises, partners with or engages inhouse or outside counsel where appropriate.

Requirements

• At least eight (8) to ten (10) years relevant legal experience; admission to at least one State bar. 
• Excellent oral and written communication skills. 
• Excellent organizational skills; demonstrates discretion and ability to maintain confidentiality of information.
• Expert understanding of state and federal laws, regulations and policies in several specialized legal areas; ability to interpret and apply such laws, regulations and policies to inform business activities.  
• Has ability to apply law from several areas to complex business situations.  Specialized legal areas within an attorney’s expertise may include: Regulatory, Market Access, Patient Support Activities, Trade, Compliance, Contracting, Environmental, Litigation and/or Antitrust, Intellectual Property.
• Strong knowledge of national business environment in which client competes.  Keeps current with evolving legal and business issues within lawyer’s broad expertise, promotes corporate policies and proactively monitors client’s business environment.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

Desired Skills, Experience and Abilities

• At least 5 years working on Life Science legal and compliance related matters, with  some experience working on legal matters associated with patient support programs, access, Specialty Care/ Rare Disease pharmaceutical products.
• Experience in FDA prescription drug  regulatory matters including  experience in the federal Anti-Kickback Statue, False Claims Act, Advertising Promotional Review, Research and Development.