The Communications Review Counsel leads activities to ensure the timely and accurate legal review to assure that Exact Sciences’ materials are compliant with laws and regulations. This role serves as the legal reviewer for materials in the U.S. for all product lines of Exact Sciences, including the Screening, Precision Oncology, Pipeline, and R&D business units. This role will serve as the legal lead on various committees for promotional materials, internal and external communications, training materials, and publications to ensure that all materials are compliant with FDA, FTC, and other relevant regulations and guidelines. The Communications Review Counsel collaborates cross-functionally to ensure materials are compliant.
Essential Duties and Responsibilities
Serves as legal reviewer for various promotional material and publication review committees, inclusive of concept reviews to ensure timely and accurate legal review.
Fosters relationships and collaborates on projects with stakeholders across multiple segments by providing legal guidance to concept reviews.
Serves as a legal consultant to cross-functional team members throughout the material development process.
Confirms that materials are consistent with relevant laws, regulations, and guidelines; including FDA, FTC, and HIPAA.
Confirms that outreach campaigns utilizing email, text messages, and facsimile are consistent with applicable law; including CAN-SPAM and the Telephone Consumer Protection Act.
Reviews the language for the appropriate level of understanding for the intended audience.
Works with Medical and Regulatory functions to ensure that presentation of materials (e.g., data, explicit claims, implied claims, studies, and analyses) are supported by sufficient evidence within the context of FDA laws, regulations, and guidance.
Ability to issue-spot and collaborate with domain experts in healthcare regulatory compliance, intellectual property, privacy, billing, etc. to ensure appropriate legal review of materials.
Works with Medical and Regulatory functions to substantiate that there is adequate evidence to support product claims, messaging, and presentations by applying the appropriate evidence for the product; e.g., FDA standards to Class III PMA devices.
Analyzes information to ensure truthful and non-misleading presentation and appropriate contextualization.
Collaborates with Marketing, Medical, and Regulatory colleagues to ensure best practices and alignment in the review environment.
Provides training, as needed, to content creators to ensure materials are developed, taking into account legal guidance.
Excellent communication, listening, and negotiation skills.
Excellent organizational and time management skills; ability to manage multiple ongoing projects simultaneously.
Committed to achieving goals and passionate about furthering the Exact Sciences’ mission.
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
Support and comply with the company’s Quality Management System policies and procedures.
Regular and reliable attendance.
Ability to work designated schedule.
Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
Ability to travel to company locations, as needed.
Qualifications
Minimum Qualifications
Juris Doctor (J.D.) degree.
3+ years of experience in the Legal/Compliance function of a company in the healthcare, pharmaceutical, medical device, life sciences, and/or clinical laboratory industries; or equivalent experience in private practice advising such companies.
Strong knowledge of U.S. regulatory standards related to communication and dissemination of promotional collateral and medical information; including FDA and FTC.
Strong knowledge of privacy laws; including HIPAA, TCPA, and CAN-SPAM.
Must hold and maintain an active license to practice law.
Authorization to work in the United States without sponsorship.
Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Preferred Qualifications
2+ years in a review committee environment for medical device or pharmaceutical products.
Experience with healthcare fraud and abuse laws; e.g., state and federal anti-kickback statutes.
Experience with a publicly traded company.
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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.