Independent Contractor – Clinical Trials Quality & Compliance Manager
Cardiovascular Associates of America - CVAUSA
Google Cloud Platform
Regulatory Affairs Manager, Ad Promo Review – Professional Education Focus
axogen
full-time
Posted on:
Location Type: Remote
Location: Remote • Florida • 🇺🇸 United States
Visit company websiteSalary
💰 $110,585 - $138,231 per year
Job Level
JuniorMid-Level
About the role
- Review HCP education materials (e.g., slide decks, speaker notes, faculty training content, invitations, agendas, registration pages, handouts, post-event follow-ups, and enduring/on-demand content) for compliance with labeling, balance, and substantiation standards.
- Distinguish scientific exchange/education from promotion; advise on appropriate context, disclosures, and disclaimers to align with APLB expectations.
- Provide clear, actionable comments/redlines and risk-ranked recommendations; escalate complex or high-risk issues as appropriate.
- Prepare and export Form FDA 2253 packages from PromoMats (and associated artifacts) and handoff to Regulatory Operations for submission to FDA (CBER/APLB).
- Participate in Medical, Legal, & Regulatory (MLR)/Promotional Review Committee (PRC) discussions, aligning with Medical and Legal on recurring claims, FAQs, and event timelines (e.g., congress symposia, speaker trainings).
- Contribute to creation and maintenance of checklists, guidance notes, and pre-approved claims/templates to streamline Professional Education content development and reduce rework.
Requirements
- Bachelor’s degree in a scientific, healthcare, communications, or regulatory discipline preferred; advanced degree (MS, PharmD, PhD, JD) desirable. Equivalent relevant experience considered in lieu of degree.
- 1–2 years of advertising and promotional regulatory review experience in pharma/biotech (required).
- Experience directly reviewing Health Care Provider (HCP) Professional Education/seminar content (preferred but not required).
- Working knowledge of CBER/APLB requirements for promotional and educational materials (e.g., fair balance, consistency with labeling, substantiation; scientific exchange vs. promotion).
- Familiarity with Veeva PromoMats for review and export of 2253 packages; proficiency in MS Office 365 (Word, Teams, Excel) and Adobe Acrobat.
- Excellent oral/written communication, redlining, and annotation skills; ability to interpret clinical/scientific data and translate into compliant claims/visuals.
- Strong organizational skills with the ability to manage multiple deadlines and shifting priorities; collaborative, solutions-oriented working style.
- Ability to travel approximately 10%-20%.
Benefits
- Health, Dental, Vision
- Matching 401K
- Paid Time Off
- 9 Paid Holidays + 3 Floating Holidays
- Dependent Care Flexible Spending Accounts
- Medical Flexible Spending Accounts
- Tuition Reimbursement
- Paid Parental Leave
- Paid Caregiver Leave
- Basic Life Insurance
- Supplemental Life Insurance
- Employee Stock Purchase Plan
- Disability Insurance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory reviewcompliance standardsscientific exchangerisk assessmentcontent developmentclinical data interpretationredliningannotation
Soft skills
oral communicationwritten communicationorganizational skillscollaborative working stylesolutions-oriented mindset
Certifications
Bachelor's degreeadvanced degree (MS, PharmD, PhD, JD)
