Senior Scientific Director at Prime overseeing scientific work and client communication strategies. Leading high - quality delivery and driving business growth in healthcare communications.
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Hybrid Director, Advertising and Promotional Material
Posted 4 months ago
About the role
- Lead end-to-end regulatory review and approval of global promotional materials for Insulet's Omnipod medical device platform; manage teams, SOPs, Veeva, and cross-functional compliance.
Responsibilities
- Own and manage the global advertising and promotional material lifecycle—from concept development through regulatory review, approval, and post-market monitoring
- Establish and maintain robust SOPs and workflows for promotional material creation, review, and approval across all regions
- Serve as the process owner for promotional review systems (e.g., Veeva Vault), ensuring timely and compliant execution
- Lead continuous improvement initiatives to streamline review cycles and enhance cross-functional collaboration
- Lead the formal review and approval process for all promotional materials, ensuring compliance with FDA regulations (21 CFR Part 801, 812), EU MDR Article 7, and other applicable global standards
- Chair the cross-functional review body, coordinating input from Regulatory, Legal, Clinical, and Medical Affairs
- Maintain documentation and audit readiness for all approved materials, including substantiation of claims and version control
- Monitor evolving regulatory guidance and proactively update processes and training to ensure ongoing compliance
- Partner with Marketing, Product Management, and Clinical teams to ensure promotional messaging is accurate, evidence-based, and aligned with product labeling and intended use
- Provide strategic input during campaign planning to ensure regulatory feasibility and risk mitigation
- Oversee the development of promotional assets including digital campaigns, print collateral, social media content, and trade show materials
- Lead and mentor a team of regulatory reviewers and marketing professionals involved in promotional content development
- Develop and deliver training programs for internal stakeholders on compliant advertising practices and regulatory expectations
- Foster a culture of accountability and excellence in promotional compliance
Requirements
- Bachelor’s degree in Life Sciences, Marketing, Communications, or related field; advanced degree preferred
- 10+ years of experience in medical device advertising and promotional review
- At least 5 years in a leadership role
- Deep knowledge of FDA, EU MDR, and global regulatory requirements for medical device advertising and labeling (including 21 CFR Part 801, 812; EU MDR Article 7)
- Proven experience managing promotional review processes and systems (e.g., Veeva Vault)
- Strong leadership, communication, and project management skills
- Ability to translate complex regulatory requirements into actionable guidance for marketing teams
- Experience with global regulatory environments (e.g., Canada, LATAM, APAC) (preferred)
- Familiarity with digital marketing compliance, including social media and influencer content (preferred)
- Strong analytical skills and attention to detail in claim substantiation and risk assessment (preferred)
- Comfortable working in a matrixed organization with multiple stakeholders
- Willingness to travel up to 25%
Benefits
- Hybrid working arrangements
- Up to 25% domestic and international travel (role requirement)
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