Associate Director, Regulatory Advertising and Promotion (contract) 24851

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.

This is a 6 month contract covering paternal leave

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

Minimum Requirements:

• 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

$100-$120/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice.   Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners

(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com.

If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors