What are the responsibilities and job description for the Associate Director, Regulatory Affairs - Advertising and Promotions position at Planet Interactive?
Job Description
Planet Interactive is seeking a remote Associate Director, Regulatory Affairs - Advertising and Promotions to join our client that is a global biotechnology company focused on developing and commercializing transformative therapies for people with serious diseases.
Pay: $100-$120/hr depending on experience
Location: Remote (EST hours)
Associate Director, Regulatory Affairs - Advertising And Promotions Responsibilities
Planet Interactive is seeking a remote Associate Director, Regulatory Affairs - Advertising and Promotions to join our client that is a global biotechnology company focused on developing and commercializing transformative therapies for people with serious diseases.
Pay: $100-$120/hr depending on experience
Location: Remote (EST hours)
Associate Director, Regulatory Affairs - Advertising And Promotions 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.
- Bachelor’s degree in relevant/scientific discipline or a related field.
- 8 years of experience or the equivalent combination of education and experience.
- 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.
Salary : $100 - $120
