Position Overview

　　The Manager, Regulatory Affairs, Advertising and Promotion is responsible for managing and coordinating the regulatory affairs review of advertising and promotional materials; including, but not limited to, product labeling, press releases, peer reviewed scientific publications and presentations for all Exact Sciences' businesses and subsidiaries (e.g., Genomic Health Inc.), and international materials translated into English from the local targeted language, as needed. This role will collaborate with a cross-functional team comprised of representatives from marketing, legal and others in Exact Sciences' medical legal regulatory (MLR) process. Additionally, the establishment, management, and development of a regulatory affairs team responsible for executing the review of the advertising, promotional, and other applicable commercial collateral materials for all Exact Sciences' businesses, subsidiaries, and project teams are within scope of this position. This position will be the primary regulatory affairs liaison with the MLR process team.

　　This position is remote.

　　Essential Duties

　　Include, but are not limited to, the following:

　　Lead the establishment of a regulatory affairs team responsible for the management and processing of the regulatory review of advertising, promotional, and other associated materials. Contribute to the continuous improvement of the MLR review process and meet established performance process metrics.Lead the professional development of the regulatory affairs advertising and promotion review team.Review, provide content, edit recommendations, and approve advertising, promotional, and other applicable commercial collateral materials; including, but limited to, press releases, customer communications, social media postings, and scientific information (e.g., abstracts, presentations, and peer reviewed journal publication drafts), as needed. All reviews and the approved materials are to be in compliance with Exact Sciences corporate, domestic, and global regulatory requirements (e.g., FDA, FTC).Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry and contribute to and/or lead internal continuing education activities to support regulatory knowledge sharing.Control and maintain regulatory records.Confer with other regulatory affairs subject matter experts regarding regulatory requirements of new product designs and changes to existing designs.Review and approve product labeling and marketing material. Initiate new package inserts and other required product labeling in alignment with registration strategies.Pursue continuously regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics; including, but not limited to, FDA regulations and policies applying to medical devices (e.g., PMAs, 510(k)s, and post-market reporting), labeling and promotional materials, global registration, and technical writing.Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.Communicate goals clearly to employees to ensure understanding and success in achieving them.Motivate and inspire employees to do their best work through coaching.Maintain morale and support employee engagement initiatives.Excellent leadership skills for a diverse team with specialized expertise.Excellent technical writing skills.Effective communication; ability to convey messages in a logical and concise manner and consistently reinforce regulatory expectations and requirements.Exceptional attention to detail.Strong organizational skills.Independent self-starter; manage time effectively and complete tasks on-time with minimal supervision. Flexible and able to self-manage multiple priorities.Adapt readily to changes in workload, staffing, and scheduling.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.Maintain regular and reliable attendance.Ability to act with an inclusion mindset and model these behaviors for the organization.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 75% of a typical working day.Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

　　Minimum Qualifications

　　Bachelor's Degree in Physical or Life Sciences, or related field as outlined in the essential duties.5+ years relevant regulatory experience in regulated pharmaceutical or medical device environment, with a focus or the inclusion of advertising and promotional material review.3+ years of experience reviewing and approving product advertising and creating product labeling.Excellent leadership skills for a diverse team with specialized expertise.Basic computer skills to include Internet navigation, Email usage, and word processing.Proficient in Microsoft Office programs.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

　　Master's in Life Sciences or related field as outlined in the essential duties.Regulatory Affairs Professional Society (RAPS) certification.3+ years of experience as a people leader responsible for the management, coaching, and development of at least one direct report.

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　　Salary Range:

　　$105,000.00 - $168,000.00

　　The annual base salary shown is a national range for this position on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms, conditions, and eligibility requirements of the applicable plans.

　　If you require a reasonable accommodation with the application process, please email [email protected].

　　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.

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