Regulatory Promotional Review Specialist

🔥 14 minutes ago

🇺🇸 United States – Remote

💵 $70k - $85k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Evergen (Formerly RTI Surgical)

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1998

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Evergen is a world-class Contract Development and Manufacturing Organization (CDMO) with a 25-year history of innovation in regenerative biomaterials. Formerly known as RTI Surgical, Evergen partners with innovative companies to accelerate the design, development, and manufacturing of life-changing regenerative medicine therapies. Their commitment to quality and safety has led to over 17 million life-enhancing implants, reflecting their dedication to providing patient-centric biomaterial solutions for effective healing.

📋 Description

• Coordinate the review and approval of advertising, promotional, and other applicable commercial materials throughout the review lifecycle • Perform submission-readiness screening to confirm materials are complete, appropriately supported, and ready for review • Serve as the primary promotional-review process liaison for internal stakeholders and external business partners • Provide guidance on submission requirements, review expectations, timelines, and status • Partner with Compliance, Clinical/Medical, Marketing, Legal, Regulatory Affairs, Commercial, and other applicable functions • Identify and escalate potential review issues related to claims, labeling, intended use, internal policies, brand guidelines, or other requirements • Monitor review progress, timelines, and outstanding actions; follow up with reviewers and escalate delays or bottlenecks • Maintain promotional review documentation, approval records, version control, and final approved materials • Coordinate promotional review committee meetings, including agenda preparation, meeting materials, reviewer comments, decisions, and follow-up actions • Ensure promotional review records are maintained and accessible for audit or inspection purposes • Develop and maintain promotional review metrics for workload visibility, cycle time monitoring, and process improvement • Support development and continuous improvement of promotional review workflows, SOPs, and best practices

🎯 Requirements

• Bachelor’s degree in life sciences, pharmacy, communications, regulatory affairs, healthcare, business, or a related field • 3+ years of experience in promotional review, regulatory affairs, advertising and promotion review, medical review support, or a related compliance/regulatory function • Experience working in a regulated life sciences industry, such as medical devices, pharmaceuticals, or biotechnology • Strong understanding of promotional material review processes and document control practices • Excellent organizational skills with the ability to manage multiple review cycles and deadlines • Strong written and verbal communication skills • Ability to work effectively across cross-functional teams and manage competing priorities • Experience within a Regulatory Affairs function preferred • Experience working with external business partners, agencies, or other third parties preferred • Familiarity with promotional review systems such as Veeva PromoMats, Vodori, Aprimo, or similar platforms preferred • Understanding of advertising, labeling, and promotional requirements in regulated environments preferred • Knowledge of material lifecycle management, submission standards, and audit documentation practices preferred • Regulatory Affairs Certification (RAC) or similar credential preferred • Ability to move or lift objects up to 25 pounds • Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays • Frequent (>75%) fine manipulation using hands and fingers

🏖️ Benefits

• Annual bonus opportunity up to $3,000 • Paid Time Off (PTO) • 401(k) with up to a 6% company match • Holiday pay • Medical, dental, and vision insurance • Short-term and long-term disability coverage • Paid parental leave