AdMonsters

Associate Director Regulatory Advertising and Promotion

Vertex Pharmaceuticals
Boston, Massachusetts, United States
30+ days ago

Description

Job Description

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:
  • Provides specialized knowledge on regulations and requirements governing product promotion and related communications in the US, 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 representative on program and other cross-functional teams
  • Serves as Chair of review committee for assigned product(s) and therapeutic area(s), leading discussions between Regulatory, Legal, Medical, Commercial and other stakeholders to reach consensus 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 provides regulatory interpretations of applicable guidance and/or regulations or regulatory precedents, including requirements related to submission of material to OPDP/APLB and interactions with OPDP/APLB, as needed
  • Provides guidance and input for development products reflective of promotional considerations, including assessment of potential labeling claims
  • Provides direction and works 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 internal review 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 regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments in the US
  • In-depth understanding of clinical study design and statistical analyses in assessment of promotional claims
  • Strong interpersonal and communication skills and ability to communicate difficult concepts and influence others
  • Ability to innovate, analyze, and solve problems
  • Pharmaceutical industry and regulatory ad/promo experience, including interacting with OPDP/APLB


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

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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. 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 ApplicationAssistance@vrtx.com.

Job Information

  • Job ID: 58734263
  • Location:
    Boston, Massachusetts, United States
  • Position Title: Associate Director Regulatory Advertising and Promotion
  • Company Name: Vertex Pharmaceuticals
  • Job Function: Other / Not Listed
  • Job Type: Full-Time

At Vertex, we bring together the brightest minds in the relentless pursuit of creating transformative medicines for people with serious and life-threatening diseases. Founded in 1989 in Cambridge, Massachusetts, we are one of only a handful of biotechnology companies founded since 1976 that has discovered and developed four or more approved medicines in our own labs. In addition to the four medicines we’ve developed to treat the underlying cause of cystic fibrosis, we have ongoing research programs focused on the underlying ...

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