Eli Lilly

Associate Director - Global Regulatory Affairs - Product Communications

Eli Lilly • $132K — $193K *
US-AnywhereRemote in Indianapolis, IN
Pharmaceuticals & Biotech
Less than 5 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's Degree
  • 3+ years of industry-related experience in drug development and/or commercialization
  • Knowledge of FDA procedures and practices (CFR guidelines, guidances, etc.)
  • Strong communication skills, including active listening, verbal, and written
  • Demonstrated ability to influence without authority and deliver complex projects against timelines
  • Recent experience reviewing advertising and promotional materials for prescription drug products
  • Awareness of evolving regulatory reform initiatives and pending changes.

Responsibilities

  • Serve as Regulatory representative for US brand and medical affairs teams
  • Provide high quality, prompt regulatory advice for well-informed decision making
  • Communicate regulatory expectations based on OPDP feedback and applicable laws
  • Contribute to business risk mitigation strategies in advertising and medical communication
  • Build and maintain relationships to influence effective communications
  • Initiate promotional tactic discontinuation plans when necessary
  • Counsel partners on OPDP advisory strategy and review promotional proposals

Benefits

  • Company-sponsored 401(k) and pension
  • Comprehensive medical, dental, vision, and prescription drug benefits
  • Flexible spending accounts for healthcare and dependent care
  • Vacation benefits and time off
  • Life insurance and death benefits
  • Employee assistance and fitness benefits
  • Eligibility for company bonus based on performance.
Full Job Description
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.)


Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$132,000 - $193,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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