Director & Sr. Counsel II - Pharmaceutical / Life Science

Director & Sr. Counsel II - Pharmaceutical / Life Science

Description

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, as the risks associated with incomplete advice are high. You will play a pivotal role supporting Boehringer Ingelheim’s U.S. Human Pharmaceutical Business, particularly our Medicine, R&D and selected therapeutic areas. Duties include drafting of legal documents and provision of legal counsel. 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., Transactions, FDA Regulatory, Commercial, Litigation, Clinical Trials, etc.) 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.

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

1. Collaborate with Medicine and Regulatory Affairs, internal asset teams and other business partners regarding communications, marketing, and promotional activities in compliance with applicable laws and regulations.
2. Provide day-to-day advice on Medicine strategy and engagements.
3. Counsel on day-to-day activities such as sweepstakes, contests, rebates, coupons, gift cards, email marketing, text message marketing, charitable marketing, advertising copy review, claim substantiation, and privacy compliance.
4. 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.
5. Prepares complex legal documents, including letters, notices, legal opinions, contracts, patent or trademark applications, court/administrative filings, licenses, corporate documents, etc. Often supervises more junior attorneys in the drafting of such documents.
6. Expert understanding of state and federal laws, regulations and policies in several specialized legal areas; strong working knowledge of laws, regulations and policies in at least one other specialized legal area; ability to interpret and apply such laws, regulations and policies to inform business activities.
7. Influences clients by identifying and communicating to clients risks associated with complex business activities within lawyer's broad understanding of several specialized legal areas.
8. Partners with clients by considering immediate business/legal issues in a broader business context and identifying broader business purposes and objectives.
9. Expected by business management to take the lead in negotiating on behalf of client to achieve solutions that attain business objectives.
10. Confers with other in-house and outside counsel where appropriate.
11. Manages (either directly or indirectly) administrative assistants, paralegals and other personnel within department. May manage more junior attorneys.
12. Strong knowledge of national business environment in which client competes. Keeps current with evolving legal and business issues within lawyer’s broad expertise.

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.

Desired Skills, Experience and Abilities

• At least 5 years working on Life Science legal and compliance related matters, with experience working on legal matters associated with 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.