Product Counsel, North America

2 days ago

Bridgewater NJ, United States EUSA Pharma Full time

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in hematology, endocrinology, metabolic, and oncology franchises. RRD is dedicated to fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.Reporting StructureReports To:    Vice President, Legal and Compliance
Direct Reports:    None
Areas Managed:    Legal and Regulatory issues from Commercial and Medical TeamsOverviewThe Product Counsel, North America will be responsible for reviewing promotional, nonpromotional, payer, and scientific materials, contracts, evaluating strategic and tactical commercial/brand, market access, patient support and medical affairs plans, supporting clinical educator programs, and advising clients on a broad array of issues relating to advertising, marketing, promotional review, patient marketing, patient support, payer presentations, and social media.Essential Duties and Responsibilities•    This is a dynamic role giving advice on legal and regulatory issues as they arise from the marketing, sales, market access, and US medical teams.
•    The Product Counsel will work on cross-functional business teams.
•    Advising on the review of promotional materials and tactics including social media and healthcare professional and consumer-directed advertising as well as nonpromotional/scientific pieces and scientific exchange materials.
•    Advising on healthcare economic and payer presentations.
•    Advising on market access strategies and patient support initiatives.
•    Draft and reviewing clinical and commercial contracts.
•    Participating in review committee meetings.
•    Advising on specific regulatory or legal risks.
•    Monitoring marketing and scientific programs.
•    Provide timely advice and training on new laws and regulations impacting the marketing of pharmaceutical drugs and scientific exchange.
•    Demonstrate high standards of conduct and ethics as well as appropriate judgment, independence, and discretion.
•    Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.
•    Perform additional duties as may be assigned.Education and Experience•    Juris Doctorate (J.D.) or LLM degree from a nationally recognized law school.
•    Admitted to the Bar of at least one state and eligible for admission to the New Jersey Bar as in-house counsel.
•    A minimum of 3 years of relevant experience. Prior experience as a member of an in-house legal department at a biotechnology or pharmaceuticals company strongly preferred.
•    Experience with FDA laws and regulations, promotional and non-promotional review.
•    Excellent critical thinking skills: ability to work through complex issues.
•    Strategic, analytical thinker and creative problem solver who possesses innovation, client management, demand management skills and regulatory knowledge.Knowledge and Skills•    Ability to be proactive, exercise judgment and manage multiple responsibilities simultaneously.
•    Strong organizational skills with the ability to handle and prioritize a high volume of work.
•    Proficiency in Microsoft Office.
•    Strong written and verbal communication skills.Work EnvironmentThis job operates in a professional office environment. Based upon job requirements, the employee may be required at times to attend meetings including travel out of province over weekends and nights. The employee must be able to freely operate and travel by car and train/plane modes of transportation. The employee is required to have a valid driver’s license and passport.Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via a commercial air carrier. This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.Location/Travel•    This position is based at RRD’s Headquarters in New Jersey.
•    Minimal travel required – international travel required.FLSA Classification•    This position is considered Exempt.EEO StatementRecordati Rare Diseases values the diversity of its workforce and welcomes applications from all qualified applicants. It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, provincial, or municipal law. Recordati Rare Diseases will provide reasonable accommodation for qualified individuals with disabilities.DisclaimerThis job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.

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