Associate Director Regulatory Advertising and Promotion contract 24851
Associate Director Regulatory Advertising and Promotion contract 24851
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job 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 crossfunctional teams and manages regulatory aspects of review and approval of communications and activities to ensure that the organizations 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 crossfunctional 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 diseasestate 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 crossfunctional 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 devices (if applicable) and investigational treatments in the US
- Indepth 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:
- Bachelors degree in relevant/scientific discipline or a related field
- Typically requires 8 years of experience or the equivalent combination of education and experience
Pay Range
$100$120/hr
Requisition Disclaimer
This job posting is for a temporary role with a thirdparty 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 thirdparty 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 jobrelated 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 Vertexs 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 employmentrelated 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 .
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 Please include the job title in the subject of your email.
No C2C or ThirdParty Vendors
Required Experience:
Director
Employment Type
Remote
Company Industry
Department / Functional Area
Regulatory Affairs
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
