Director, US Promotional Compliance & Scientific Messaging

Lundbeck; Boston (MA); Vor Ort; USD 200.000 - 225.000; Vollzeit

Benefits dieser Stelle

Health, dental and vision benefits

401k with company match

Flexible PTO

Bonus program

Zusammenfassung

Lundbeck in Boston seeks a Director of Promotion Compliance and Scientific Messaging to lead advertising, promotion strategy, and external communications for US products. You will partner with Commercial, Medical, Legal, and Market Access to ensure compliant and impactful messaging.

In this highly visible role, you will shape launch concepts, review promotional materials, manage FDA interactions, and guide cross-functional teams through complex regulatory reviews while balancing business needs

Qualifikationen

• Bachelor’s degree in life sciences or related field.
• 10+ years in R&D/regulatory with 5+ years in advertising/promo messaging.
• Hands-on US pharma advertising regulatory experience across audiences.
• Lead complex promotional review with FDA guidance interpretation.
• Strong knowledge of FDA requirements for prescription drugs and biologics.
• Ability to assess regulatory risk and communicate findings clearly.
• Strategic leadership to influence cross-functional teams in a matrixed environment.
• Experience supporting product launches and lifecycle management from promo perspective.

Aufgaben

• Serve as US regulatory advertising and promotion strategic partner for assigned brands.
• Lead regulatory review of claims and promotional materials for FDA compliance.
• Represent regulatory in MLR reviews and cross-functional forums; negotiate positions.
• Provide early regulatory guidance on HCP, DTC, payer communications and digital content.
• Lead regulatory aspects of launch planning and promotional materials.
• Manage interactions with FDA/OPDP and advisory comment processes.
• Collaborate with brand teams and stakeholders to balance regulatory and business needs.
• Develop and communicate regulatory positions and risk-based decisions.
• Provide coaching and SME support to regulatory colleagues and teams.
• Monitor evolving US advertising environment and translate to actionable recommendations.

Kenntnisse

Regulatory leadership

FDA/OPDP expertise

Strategic cross-functional influence

Negotiation and communication

Regulatory risk assessment

Ausbildung

Bachelor’s degree

Life sciences or related field

Advanced degree (PhD/PharmD/MBA)

Jobbeschreibung

Lundbeck in Boston seeks a Director of Promotion Compliance and Scientific Messaging to lead advertising, promotion strategy, and external communications for US products. You will partner with Commercial, Medical, Legal, and Market Access to ensure compliant and impactful messaging.

In this highly visible role, you will shape launch concepts, review promotional materials, manage FDA interactions, and guide cross-functional teams through complex regulatory reviews while balancing business needs