click here.Duties & Responsibilities
* 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.
Provide day-to-day advice on Medicine strategy and engagements.
* 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.
* 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, patent or trademark applications, court/administrative filings, licenses, corporate documents, etc. Often supervises more junior attorneys in the drafting of such documents.
* 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. Has ability to apply law from several areas to complex business situations. Specialized legal areas within an attorney's expertise may include: Regulatory, Trade, Compliance, Contracting, Environmental, Litigation and/or Antitrust, Intellectual Property.
* Influences clients by identifying and communicating to clients risks associated with complex business activities within lawyer's broad understanding of several specialized legal areas, which specialized legal areas may include: Regulatory, Trade, Compliance, Contracting, Environmental, Litigation and/or Antitrust, Intellectual Property; 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.
* Expected by business management to take the lead in negotiating on behalf of client to achieve solutions that attain business objectives.
* Confers with other in-house and outside counsel where appropriate. Also advises, partners with or engages inhouse or outside counsel where appropriate.
* Manages (either directly or indirectly) administrative assistants, paralegals and other personnel within department. May manage more junior attorneys. Mentors and/or trains more junior attorneys, paralegals, administrative assistants and/or other personnel within department. Takes on other departmental administrative responsibilities within the legal department consistent with the objectives of the legal department.
* 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.
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.
PDN-9e653a6b-ac5c-49a7-9c29-e1e2b0f24d78