Associate Director – Global Regulatory Affairs, Product Communications

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $132k - $193.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Provide leadership and influence to deliver accurate, balanced, and substantiated product and disease communications for assigned assets • Partner with Regulatory Scientists, Lilly brand teams, partner companies, and FDA Office of Prescription Drug Promotion (OPDP) to advise on regulatory requirements and expectations • Serve as Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications • Review promotional tactics, internal field-based communications, medical affairs communications, campaign tactics, press materials, and investor relations communications • Provide prompt and conclusive regulatory advice to enable well-informed business decisions • Communicate regulator expectations using OPDP feedback, applicable laws, regulations, guidances, and FDA enforcement actions • Contribute to business risk mitigation strategies by following advertising, promotion, and medical communication trends • Build and maintain relationships with Lilly team members and partner companies • Initiate promotional tactic discontinuation plans for Regulatory-initiated events • Counsel internal partners on OPDP advisory strategy and collaborate on promotional proposals and submission documents • Partner with US brand teams to interpret OPDP advice and support interactions with OPDP • Review Form 2253 promotional material submissions to FDA • Engage US Regulatory Scientists in promotional claims, marketing strategy, press materials, and investor relations communications • Lead labeling revisions with US Regulatory Scientists and Labeling Operations • Communicate key information to support execution of US regulatory strategy and promotional activity • Engage in forums sharing regulatory information across the organization and business partners • Constructively challenge teams and lead open discussions to achieve robust business decisions

🎯 Requirements

• Bachelor's Degree • 3+ years of industry-related experience in drug development and/or commercialization • 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 • Knowledge of FDA procedures and practices, including CFR guidelines and Guidances • Ability to influence without authority and deliver complex projects against a timeline • Strong communication skills, including active listening, verbal, and written communication • Ability to apply systematic thinking/mindset to business problems and opportunities • Effective teamwork skills and ability 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

🏖️ Benefits

• Company bonus depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities