New York based Global biotechnology company focusing on creating life changing products for the treatment of cancer is seeking an experienced FDA brand attorney who will support the needs of the hematology customer facing business, including Commercial, Medical Affairs, and Regulatory Affairs.
- Healthcare Compliance Experience– Advise on various federal and state regulatory requirements such as Federal and State Open Payments regulations, Stark and Anti-Trust regulations, and Federal and State Fraud and Abuse laws including the Anti-Kickback Statue, the False Claims Act, and FCPA).
- Promotional Review/ Brand Attorney Experience: Lead attorney on the company’s current cancer treatment’s Promotional Review Committee (PRC), who will review promotional materials for hematology and marketing and sales tactics including healthcare professional and consumer-directed advertising as well as non-promotional/scientific pieces and scientific exchange materials.
- Reviews medical affairs and brand plans for the company’s current cancer treatment and pipeline hematology products
- Reviews advisory board plans, speaker nomination forms, and proposed engagement of HCPs for consulting purposes, for compliance with relevant laws and company policies
- Advises on FDA compliance and anti-kickback risks
- Reviews the company’s current cancer treatment and hematology social media materials and press releases with respect to compliance with relevant laws as well as company policies
- Provides strategic advice regarding customer and stakeholder relationships, regulatory matters, contracts and interactions with respect to branded/specialty pharmaceuticals.
- Provides strategic advice to marketing, medical affairs, market access, and sales with respect to hematology products, including pipeline products.
- Works closely with contracts attorneys and paralegals and advises on specific regulatory or compliance risks
- Works with Compliance function; and deliver internal training in areas of healthcare compliance and commercial transactions, such as anti-corruption, FDA laws, records retention and other laws, regulations and internal policies.
- Assists in the development of company policies and procedures; may assist in monitoring and auditing
- Works with ex-US colleagues to ensure coordination hematology product strategy between U.S. and EU and ROW; may review EU materials as part of PRC.
- Assists with the company’s current cancer treatment’s launch issues in ex-U.S. countries, including trademark issues
- JD with at least 2-5 years’ experience as a brand attorney in house or as life sciences attorney in a law firm is required; licensed to practice in New York or if not licensed in New York, must be licensed attorney in another state and be willing and able to complete in house NY registration. Must be attorney in good standing and willing to undergo background check.
- Strong communication skills both verbal and written, are
- Strong negotiation
- Strong skills in attention to detail, resourcefulness, and follow-through.
- Individual must be able to work both independently and in a team
- Compliance experience with FDA and governmental regulations required.
- Ability to manage multiple tasks simultaneously and efficiently, strong negotiation and interpersonal skills are
- Must possess the proven ability to develop effective interdependent partnering relationships with the ability to collaborate with business partners and clients effectively, spending the appropriate amount of time listening to their concerns and needs showing respect and valuing their roles and ensuring that their needs and business goals are met in a timely and effective
- Must exhibit a high level of integrity and willingness to find effective and compliant solutions with minimal supervision or direction using a high degree of independent analytical
- Must possess strong verbal and written skills, including the ability to communicate and collaborate effectively with others at all levels of the
- Experience with hematology products and/or rare diseases is desirable
Salary commensurate with experience. Compensation package includes bonus and long term incentive plan. Fully remote role.Submit Resume