Regulatory Compliance Manager – Advertising and Promotion

Summary of Major Responsibilities

The Regulatory Compliance Manager, Advertising and Promotion is responsible for independently managing regulatory compliance activities and maintaining marketing privileges consistent with applicable government requirements. Specifically, this position is responsible for establishing and maintaining the regulatory strategy associated with advertising and promotional activities to compliantly promote medical devices. The Regulatory Compliance Manager – Advertising and Promotion provides strategic direction and support, in alignment with pertinent regulatory requirements, for current and new promotional strategies. 

Essential Duties and Responsibilities

  • Provide regulatory consultation/advice to Marketing, Sales Force Effectiveness, Medical Affairs, Commercial Operations, Clinical Affairs, R&D and other functions as needed with regards to promotional and medical/scientific materials and activities to support commercialized products.
  • Serves as Regulatory SME in the cross functional promotional materials approval process.
  • Develops and manages translation of registered claims into promotional communications, as applicable.
  • Maintains Good Promotional Practices in conjunction with the core MLR team.
  • Participates on project teams to provide appropriate information on regulatory issues and obtain information to meet regulation requirements.
  • Maintains current knowledge base on existing and emerging regulations, standards and guidance documents.
  • Supports organizational compliance with FDA regulations and international product registrations.
  • Creates and maintains Regulatory Affairs SOPs.
  • Develops and presents training and/or training modules for the organization as needed on various Ad/Promo topics.
  • Monitors Exact Sciences’ and social media outlets for content, accuracy and compliance to promotional messaging.
  • Influences cross-functionally to support compliance within the organization through continuous education.
  • Reviews and assesses changes in the regulatory landscape impacting promotional activity.

Qualifications

Minimum Requirements

  • Proven ability to lead independently and work effectively with and through multi-functional teams to achieve results.
  • Strong working knowledge and experience of FDA regulations and requirements, with demonstrated success integrating regulatory requirements and guidance for advertising, promotion or other commercial communication into projects.
  • Extensive experience with FDA and/or international registration requirements applicable to commercialization or promotional activities.
  • Development, interpretation or application experience with standards, guidelines and special controls.
  • Medical device submission experience with specific experience preparing 510(k), IDE and PMA submissions or equivalent regulatory compliance support of medical device promotion.
  • Highly organized and able to manage multiple projects and deadlines under strict time lines.
  • Strong interpersonal skills and verbal communication skills with the ability to listen, articulate and advocate.
  • Three years minimum experience with regulatory compliance of medical device or pharmaceutical promotion.

Education and Experience

  • Master’s degree in physical or life sciences and minimum three years of relevant experience; or a Bachelor’s degree in physical or life sciences and minimum five years of relevant experience.
  • Five years minimum medical device or pharmaceutical industry experience.
  • Experience leading others is preferred.

Physical Requirements

  • Ability to use computers daily in an interactive manner for extended periods of time.
  • Ability to frequently and accurately communicate with employees in person, via the telephone or by email.
  • Ability to sit or stand for an extended period of time.
  • Ability to travel domestically and internationally (<10%).

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EEO Disclosure

Exact Sciences is 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 is available to any applicant or employee for inspection upon request. 


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