Associate Director - Global Regulatory Affairs - Product Communications

Organization Overview:

The purpose of the Associate Director, Global Regulatory Affairs - Product Communications role is to provide leadership and influence to deliver accurate, balanced, and substantiated product and disease communications for assigned assets. The Associate Director partners with Regulatory Scientists, across Lilly brand teams, partner companies, and FDA Office of Prescription Drug Promotion (OPDP) to advise on regulatory requirements and expectations for compliant communications.

Responsibilities:

Within the role, the Associate Director will have the responsibility to provide regulatory guidance in the following areas:  

Review of Promotional Tactics and Communication

• Serve as Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics, internal field-based communications, medical affairs communications, and campaign tactics for media events
• Provide high quality, prompt and conclusive regulatory advice that enables business partners to make well-informed decisions
• Communicate regulator expectations by utilizing OPDP feedback received by Lilly, interpretation of applicable laws, regulations and guidances, and knowledge of FDA enforcement actions.
• Contribute to business risk mitigation strategies by following trends in external environment related to advertising, promotion and medical communication topics
• Build, maintain, and utilize relationships with Lilly team members and partner companies, as appropriate, to effectively influence the implementation of appropriate communications.
• Initiate promotional tactic discontinuation plans for Regulatory-initiated events

Facilitate Interaction with FDA OPDP

• Counsel internal partners on OPDP advisory strategy; collaborate with marketing and advertising agency in development of promotional proposals, and provide quality review of submission documents
• Partner with US brand team to interpret OPDP advice and support any interactions with OPDP
• Provide a well-timed and quality review of 2253 promotional material submissions to FDA

Collaborate with Other Regulatory colleagues

• Engage US Regulatory Scientist in 1) development and analysis of promotional claims and suggest marketing on promotional strategy and 2) review of press materials and IR communications.
• Work closely with US Regulatory Scientist and Labeling Operations to lead labeling revisions to balance consideration of business implication and regulatory compliance
• Communicate and share key information to enable seamless execution of US regulatory strategy and promotional activity

Lead/Influence/Partner

• Engage in forums that share regulatory information across the organization, other Lilly teams, and business partners
• Constructively challenge teams to reach the best solutions to issues
• Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions

Minimum Qualifications Requirements:

• Bachelor's Degree
• 3+ years of industry-related experience in drug development and/or commercialization
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Skills/Preferences:

• Knowledge of FDA procedures and practices (CFR guidelines, Guidances, etc.)
• Demonstrated ability to influence without authority and ability to deliver complex projects against a timeline.
• Strong communication skills (active listening, verbal, and written)
• Demonstrated ability to apply systematic thinking/mindset to business problems and opportunities
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
• Recent experience reviewing advertising and promotional materials for prescription drug products.
• Awareness of evolving regulatory reform initiatives and pending changes (Federal Register, media reports, etc.)