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 ComplianceDirect Reports:

Associate Director Legal OperationsAreas 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 accommodationsLocation/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 Statement Recordati 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.

Disclaimer This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.

Base Salary Range:

$180,000 to $270,000 annually. The base salary range represents the Company's good-faith estimate of the compensation range for this position at the time of posting. The actual base salary offered may vary based on factors including the candidate's qualifications, relevant experience, skills, internal equity, business needs, and geographic location, where applicable.

Annual Incentive:

This position is eligible to participate in the Company's annual bonus program, subject to the terms of the applicable plan and individual eligibility requirements.

Benefits:

Eligible employees may participate in a comprehensive benefits program, which currently includes medical, dental, orthodontia, and vision coverage; company-paid life and accidental death and dismemberment insurance; and short-term and long-term disability coverage.

Retirement Savings:

Eligible employees may participate in the Company's 401(k) retirement savings plan, subject to the terms of the plan.

Paid Time Off:

Eligible employees receive vacation, company holidays, and sick and personal time in accordance with Company policy and applicable law.

The Company reserves the right to amend, modify, or terminate its compensation and benefit programs at any time, subject to applicable law.