PRC Legal Reviewer
Job Title: PRC Legal Reviewer
Location: Remote
Job Summary: We are seeking an experienced professional to provide expert regulatory affairs support focused on advertising and promotional review activities. Our team places particular emphasis on compliance with evolving FDA regulations, ensuring high-quality and timely promotional material review for pharmaceutical products.
Responsibilities
ā¢ Conduct comprehensive regulatory reviews of promotional materials, ensuring alignment with current FDA advertising and promotional regulations.
ā¢ Participate as a regulatory reviewer in cross-functional promotional review committees, contributing to effective collaboration and regulatory compliance.
ā¢ Support ongoing business activities by managing high-volume promotional review demands, especially those that require shifting priorities and time-sensitive deliverables.
ā¢ Maintain awareness of FDA guidance updates and apply regulatory knowledge to the review of healthcare professional materials, direct-to-consumer campaigns, corporate materials, and related documents.
Experience/Minimum Requirements
ā¢ At least 10 years of hands-on experience in regulatory advertising and promotional review within the pharmaceutical or biotechnology industry.
ā¢ Extensive familiarity with FDA regulations and guidance relevant to advertising and promotion, including CFL guidance (required) and SIUU guidance (preferred).
ā¢ Direct experience supporting promotional review for products approved under Accelerated Approval (Subpart E) is strongly preferred.
ā¢ Proficiency with Veeva Vaults Promo mats, plus a deep understanding of clinical trial design and statistical principles to interpret efficacy and safety data.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy
Apply Now
Apply Now
Location: Remote
Job Summary: We are seeking an experienced professional to provide expert regulatory affairs support focused on advertising and promotional review activities. Our team places particular emphasis on compliance with evolving FDA regulations, ensuring high-quality and timely promotional material review for pharmaceutical products.
Responsibilities
ā¢ Conduct comprehensive regulatory reviews of promotional materials, ensuring alignment with current FDA advertising and promotional regulations.
ā¢ Participate as a regulatory reviewer in cross-functional promotional review committees, contributing to effective collaboration and regulatory compliance.
ā¢ Support ongoing business activities by managing high-volume promotional review demands, especially those that require shifting priorities and time-sensitive deliverables.
ā¢ Maintain awareness of FDA guidance updates and apply regulatory knowledge to the review of healthcare professional materials, direct-to-consumer campaigns, corporate materials, and related documents.
Experience/Minimum Requirements
ā¢ At least 10 years of hands-on experience in regulatory advertising and promotional review within the pharmaceutical or biotechnology industry.
ā¢ Extensive familiarity with FDA regulations and guidance relevant to advertising and promotion, including CFL guidance (required) and SIUU guidance (preferred).
ā¢ Direct experience supporting promotional review for products approved under Accelerated Approval (Subpart E) is strongly preferred.
ā¢ Proficiency with Veeva Vaults Promo mats, plus a deep understanding of clinical trial design and statistical principles to interpret efficacy and safety data.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy
Apply Now
Apply Now