Salary
💰 $100,000 - $130,000 per year
About the role
- Serve as a primary internal resource for compliance-related inquiries, providing timely and accurate guidance grounded in applicable laws and regulatory frameworks.
- Review and approve all informational, marketing, and promotional materials to ensure compliance with applicable standards and regulations, such as USP <795>, USP <797>, USP <800>, FDA and FTC marketing and promotion guidelines, HIPAA, and state-level requirements for both prescription and non-prescription products.
- Prioritize and manage content review requests based on business needs, deadlines, and regulatory risk, ensuring timely approvals and consistent compliance.
- Understand and advise on communications guidelines and regulatory requirements for Strive Pharmacy’s products and services, including prescription medications, OTC supplements, and other OTC products.
- Partner with the Marketing team to ensure all communications accurately represent Strive Pharmacy’s products and services and avoid misleading, unsubstantiated, or otherwise noncompliant claims.
- Support the creation, review, and ongoing refinement of standard operating procedures (SOPs) related to content compliance and promotional activities.
- Research, interpret, and apply state and federal regulatory requirements, serving as the in-house expert for applicable laws, standards, and guidance documents.
- Stay informed on evolving regulatory trends, enforcement actions, and best practices in pharmacy marketing compliance.
- Collaborate with the Legal team to ensure content aligns with broader compliance and risk management objectives.
- Develop and deliver training for the Marketing team and other related teams on compliance requirements and best practices for promotional activities.
- Maintain thorough documentation of content review processes, decisions, and approvals to support audit readiness and regulatory inspections.
Requirements
- PharmD or JD preferred.
- 5+ years of experience in pharmacy compliance, regulatory affairs, or a related role, with direct experience in content and marketing review.
- Strong knowledge of USP <795>, USP <797>, and USP <800> standards, FDA and FTC marketing and promotion guidelines, HIPAA, and applicable state laws.
- Working knowledge of HIPAA privacy requirements as they apply to marketing and promotional content.
- Proven ability to interpret and apply complex regulations to real-world scenarios.
- Proactive problem-solver who offers compliant solutions and can make sound, timely decisions.
- Ability to balance regulatory compliance with business objectives by guiding teams toward compliant alternatives that achieve marketing goals.
- Exceptional communication skills, both written and oral.
- Strong interpersonal skills with the ability to collaborate across departments and to educate and influence non-compliance stakeholders toward compliant solutions.
- Highly organized with a focus on accuracy and strong attention to detail.
- Exceptional skills in time management and prioritization, and the ability to manage multiple concurrent priorities and deadlines in a fast-paced environment.
- Proven ability to review and approve content under tight deadlines without compromising quality or accuracy.
- Commitment to ongoing professional development and staying current with regulatory changes impacting pharmacy marketing.
- Experience in writing standard operating procedures (SOPs).
- Proficient with Google Workspace and Microsoft Office.
- Experience using Asana and Canva preferred.