Director, Regulatory Affairs Advertising Promotion (Remote)
Share
Job Location:
Boston, NH - USA
Monthly Salary:
$ 182000 - 272900
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description
General Summary:
Vertex is seeking an experienced Regulatory Affairs Advertising & Promotion Director to provide strategic and tactical regulatory direction for the review and approval of product pipeline and disease state communications for its pain assets in the US. This role is critical in ensuring that all promotional and nonpromotional communications meet regulatory requirements and support Vertexs business objectives. The Director will collaborate cross-functionally to develop viable communications and implement processes that drive compliance and business success.
Key Duties and Responsibilities:
- Serve as a regulatory expert on US statute regulations and relevant guidance governing product promotion and related communications including pipeline and disease state communications for the pain franchise.
- Lead the Communications Review Committee (CRC) provide regulatory review support for the Medical Review Committee (MRC) and act as Global Regulatory Affairs Advertising and Promotion (GRAAP) representative on cross-functional teams.
- Chair the CRC for assigned products and therapeutic areas leading discussions among Regulatory Legal Medical Commercial and other stakeholders to reach consensus.
- Assess regulatory context and provide interpretations of applicable guidance regulations and precedents to proposed communications as well as interpret and manage submission requirements to Health Authorities.
- Enhance collaboration across a matrixed organization and maintain constructive relationships with CRC stakeholders.
- Provide input for development products with promotional considerations including contributions to target product profiles and proposed labeling and ensure product labeling changes are accurately reflected in promotional materials in a timely manner.
- Lead cross-functional efforts to develop update and streamline procedures and guidelines related to CRC processes.
- Monitor and interpret advertising and promotion regulations FTC and FDA compliance letters and health authority guidances to support compliant marketing of Vertex products across a variety of communication medium.
- Lead training sessions for stakeholders as needed.
Knowledge and Skills:
- High level of applied knowledge of Health Authority statutes regulations guidance and industry standards related to advertising and promotional communications for prescription drugs devices and investigational treatments.
- In-depth understanding of clinical study design and statistical analyses necessary to support promotional claims and other communications.
- Familiarity with labeling regulations and global promotional review.
- Excellent interpersonal communication (oral and written) project management and presentation skills.
- Ability to lead influence resolve conflict and drive consensus among diverse stakeholders.
- Solutions-driven mindset with strong reasoning and risk management skills.
- Experience in pharmaceutical industry regulatory advertising/promotion including managing launch campaigns and interacting with Health Authorities.
Education and Experience:
- Bachelors degree in relevant/scientific discipline or a related field
- Typically requires 10 years of experience or the equivalent combination of education and experience
#LI-EE1 #LI-Remote
Pay Range:
$182000 - $272900Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other job-related factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.
Flex Designation:
Remote-EligibleFlex Eligibility Status:
In this Remote-Eligible role you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion youre always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.
#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 persons 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
Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Vertex Pharmaceuticals invests in scientific innovation to create transformative medicines for people with serious diseases.
