Description:

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.

Are you ready to unlock your full potential?

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 devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, improved diagnoses, and enhanced treatment availability, covering endocrinology, metabolic, and oncology franchises. RRD is dedicated to excellence, fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To: Vice President, Legal and Compliance
Direct Reports: Associate Director Legal Operations
Areas Managed: Legal and regulatory business guidance regarding product development, commercialization and promotion; market access and patient support; medical affairs; privacy; and contracting.

Overview:
The Product Counsel, North America will be responsible for reviewing promotional, nonpromotional, payer, and scientific materials, evaluating strategic and tactical commercial/brand, market access, patient support and medical affairs plans, supporting commercial and non-commercial clinical and medical education initiatives, and advising clients on a broad array of advertising, marketing, promotional review, healthcare professional (HCP) and patient engagement, payer communication, and other business activities. This role will also advise on patient and data privacy requirements related to the management and storage of patient information; draft and negotiate commercial and research agreements; and oversee contract execution and lifecycle management.

Essential Duties and Responsibilities:
This is a dynamic role giving advice on legal and regulatory issues as they arise across RRD business units and activities. The Product Counsel will:

Work on cross-functional business teams and proactively develop robust partnerships with commercial and non-commercial stakeholders.
Provide timely legal and regulatory advice to business partners regarding the marketing of pharmaceutical drugs, scientific exchange, and brand lifecycle management.
Review promotional materials and tactics including HCP and consumer-directed advertising as well as nonpromotional disease education and scientific materials in accordance with current FDA and FTC regulations, guidance, and enforcement activity, and counsel on risk mitigation strategies as needed.
Advise on health economics and outcomes research (HEOR) and payer communications in accordance with applicable FDA guidance.
Draft, review, negotiate, and advise on a broad range of commercial agreements, including vendor, services, consulting, licensing, technology, and confidentiality/non-disclosure.
Support the legal needs of clinical development and research activities, including clinical trial agreements (CTAs), investigator-sponsored research (ISR/ISS) agreements, collaborative research agreements, informed consent considerations, and related data use arrangements.
Support business initiatives involving the collection, use, disclosure, and transfer of personal, patient, healthcare professional, clinical research, and other sensitive data.
Advise on third-party risk management, data processing arrangements, cybersecurity incidents, and contractual privacy and security obligations.
Track and advise senior leadership on current federal and state legal and regulatory risks and enforcement trends relevant to the life sciences industry.
Monitor commercial and medical field interactions as needed.
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 an accredited 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 5 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 federal and state regulations governing the life sciences industry.
Experience as Legal reviewer on promotional and non-promotional review committees (MLR, PRC, MRC, etc.)
IAPP CIPP certification preferred.
Healthcare Compliance certification preferred.
Excellent critical thinking skills; ability to work through complex issues.
Strategic, analytical thinker and creative

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 and the appropriate use of authorized AI tools.
Strong written and verbal communication skills.

Work Environment:
This 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 state 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 Demands:
The physical demands described here are representative of those required to successfully perform the essential functions of this position. The employee must be able to travel domestically and internationally, as business needs require. This position is primarily sedentary. The employee may occasionally move throughout office, meeting, or event locations and regularly operate a computer, telephone, and other office productivity equipment. The employee must be able to communicate effectively with internal and external stakeholders. Occasionally, the employee may be required to move or transport items weighing up to 25 pounds, with or without accommodations

Location/Travel