Associate Director – Global Regulatory Affairs, Product Communications

🕒 Setembro 1

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $132.000 - $193.600 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 9%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Eli Lilly and Company

SiteLinkedInTodas as Vagas

10.000+ funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

💰 $6.500.000 Post-IPO Debt - Eli Lilly em 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company é uma empresa farmacêutica multinacional que pesquisa, desenvolve, fabrica e comercializa medicamentos de prescrição em várias áreas terapêuticas, incluindo diabetes, oncologia, imunologia, neurociência e dor. Com sede em Indianápolis, Indiana, Lilly é conhecida por sua extensa P&D, desenvolvimento clínico e comercialização global de medicamentos biológicos e de pequenas moléculas. A empresa foca na descoberta de medicamentos, ensaios clínicos, aprovações regulatórias e fabricação e distribuição farmacêutica em larga escala.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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