Managing Compliance Counsel

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.

RRD) develops high-impact therapies for devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.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
Associate Director Legal Operations
Areas Managed: Legal and regulatory business guidance regarding product development,commercialization and promotion; market access and patient support; 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.

This is a dynamic role giving advice on legal and regulatory issues as they arise across RRD business units and activities. Work on cross-functional business teams and proactively develop robust partnerships withcommercial and non-commercial stakeholders.

Provide timely legal and regulatory advice to business partners regarding the marketing ofpharmaceutical drugs, scientific exchange, and brand lifecycle management.

Review promotional materials and tactics including HCP and consumer-directed advertising as well asnonpromotional disease education and scientific materials in accordance with current FDA and FTCregulations, guidance, and enforcement activity, and counsel on risk mitigation strategies as needed.

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 trialagreements (CTAs), investigator-sponsored research (ISR/ISS) agreements, collaborative researchagreements, 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, andcontractual privacy and security obligations.

Track and advise senior leadership on current federal and state legal and regulatory risks andenforcement trends relevant to the life sciences industry.

Monitor commercial and medical field interactions as needed.

Act in full compliance with all laws, regulations, and policies including adverse events /pharmacovigilance responsibilities.

or LLM degree from an accredited law school.

Prior experience as a member of an in-house legaldepartment at a biotechnology or pharmaceuticals company strongly preferred.

Experience as Legal reviewer on promotional and non-promotional review committees (MLR, PRC,MRC, etc.).

Healthcare Compliance certification preferred.

Strategic, analytical thinker and creative.

Proficiency in Microsoft Office and the appropriate use of authorized AI tools.

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.

The employee must be able to travel domestically and internationally, as business needs require. The employee may occasionally move throughout office, meeting, or event locations and regularly operate a computer, telephone, and other office productivity equipment. Location/Travel

This position is based at RRD's Headquarters in New Jersey.

Minimal travel required - international travel required.

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.

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.
Eligible employees may participate in a comprehensive benefits program, which currently includes medical, dental, orthodontia, and vision coverage; 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.

Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

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