Forest Laboratories, Inc. (FLI)
is an innovative, growth-oriented prescription pharmaceutical company focused on developing top-quality therapies that help people lead healthier, more fulfilling lives. We take pride in meeting our business objectives and expanding our product franchises, but we also derive satisfaction in helping to bring relief to people who are suffering. Our products treat conditions such as depression, anxiety, Alzheimer’s disease, hypertension and fibromyalgia, and we keep a focused eye on the future with a robust pipeline of compounds at virtually every stage of development. With headquarters in New York City and operations in New Jersey, Long Island, Missouri, Ohio, California, Ireland and the U.K, each of Forest’s more than 5,000 employees contributes to our quest to deliver quality products with entrepreneurial spirit, unflagging integrity and deep respect for people and community. Explore your potential to thrive with a career at Forest.
Associate Regulatory Counsel
is primarily responsible for assisting the Regulatory Counsel with the legal review of all promotional, sales training and press materials for Forest's diverse product portfolio and providing counsel to the business on advertising and promotional review, marketing strategy, sales training, speaker bureaus, compliance processes, interacting with the FDA and DDMAC, and labeling. The Assistant Regulatory Counsel's main area of responsibility will be participating as an active member of the Promotional Review Committees for launch products. The Associate Regulatory Counsel will also assist with the legal review of non-promotional medical presentations on Forest products, and assist on other legal matters as directed by the Regulatory Counsel.
Main areas of responsibility:
- Assist with the legal review of all advertising, promotional, sales training and press materials for Forest's product portfolio, including primarily launch products, and provide related legal counsel to all members of the review process.
- Advise and counsel diverse members of the business on FDA regulations, the Anti-Kickback Statue, False Claims Act and PhRMA Code in connection with product labeling, promotional activities, marketing strategies, sales training and compensation, speaker bureaus, and communications with DDMAC.
- Advise and counsel Commercial Operations, Regulatory and Medical Affairs groups with respect to projects, initiatives and communications to the public regarding products that are pending FDA approval. Provide counsel regarding potential product claims and issues during due diligence activities.
- Advise and counsel various segments of the business with regard to the collection and communication of Health Economics Outcomes Research, ("HEOR"), including HEOR data sought to be communicated to qualified audiences under FDAMA 114.
- Advise Medical Affairs with regard to medical letters, publications, and presentations by ESAs.
- Support the Regulatory Counsel as directed on special projects.
Minimum Qualifications to be considered for this position:
BA/BS and J.D are required
5+ years experience as a practicing attorney, with at least 3 years' experience in the pharmaceutical/biotech industry.
Licensed to practice law in the United States or be eligible for licensure as a registered in-house counsel.
Ideally candidates will also have:
-Knowledgeable of the laws and regulations affecting the pharmaceutical industry, including the Food Drug and Cosmetic Act, Anti-Kickback Statute, and False Claims Act.
-Excellent communication skills, including presentation capabilities, interpersonal skills and conflict resolution.
-Excellent negotiation skills requiring effective interpersonal communication and oral and written communication skills.
-Ability to independently manage workload in a fast-paced environment. Ability to provide legal counsel to a wide variety of internal clients on legal and regulatory matters and interact effectively with employees at all levels of the organization.
Forest Laboratories doesn't just blend in with the trees. The company develops and manufactures prescription drugs to address a wide...