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Job Description
General Summary:
The Advertising Promotion Associate Director is responsible for providing strategic and tactical regulatory support and guidance for assigned product and disease state communications for Vertex product(s) and/or development program(s). This role works with cross-functional teams and manages regulatory aspects of review and approval of communications and activities to ensure that the organization’s needs are met in compliance with applicable regulatory requirements.
Key Duties and Responsibilities:
Demonstrate an in-depth knowledge of the regulatory requirements associated with advertising and promotion of prescription drug products and related communications, including pipeline and disease state communications
Serves as regulatory reviewer for assigned product(s) on Communications Review Committee (CRC) and Medical Review Committee (MRC), and as Commercial Regulatory Affairs (CoRA) representative on program and other cross-functional teams
May serve as Chair of CRC for assigned product(s) and therapeutic area(s), leading discussions between Regulatory, Legal, Medical, Commercial and other stakeholders to reach consensus CRC decisions
In collaboration with Medical, Legal and Commercial, provides regulatory leadership to ensure that regulatory requirements are integrated in product and disease-state communications
As a regulatory reviewer, assesses the regulatory context and provide regulatory interpretations of applicable guidance and/or regulations or regulatory precedents, including requirements related to submission of material to Health Authority (HA) and interact with HA, as applicable
Provides guidance and input for development products reflective of promotional considerations
Provides direction and work collaboratively to ensure that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirements
Collaborates in cross-functional efforts to develop and update procedures and guidelines related to
CRC processes
Monitors and interprets advertising and promotion regulations and guidelines to support successful and compliant marketing of Vertex products and assess impact
Plans and conducts training sessions as needed with stakeholders
Knowledge and Skills:
Thorough knowledge of applicable Health Authority laws, regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments
In-depth understanding of clinical study design and statistical analyses in assessment of promotional claims
Strong interpersonal and communication skills with ability to communicate difficult concepts and
persuade others
Ability to innovate, analyze, and solve problems
Pharmaceutical industry and regulatory ad/promo experience, including interacting with health authorities
Education and Experience:
Bachelor’s degree in relevant/scientific discipline or a related field
Typically requires 8 years of experience or the equivalent combination of
education and experience
#LI-EE1 #LI-Remote
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected].