... and managed, and support the communities we serve. This is hard, urgent, selfless work-but it ... The Associate Director partners with Regulatory Scientists, across Lilly brand teams, partner ...
... and managed, and support the communities we serve. This is hard, urgent, selfless work-but it ... The Associate Director partners with Regulatory Scientists, across Lilly brand teams, partner ...
... and managed, and support the communities we serve. This is hard, urgent, selfless work-but it ... Position Brand Description: The Associate Director - QA is a partner with the Sr. Director - QA in ...
... and managed, and support the communities we serve. This is hard, urgent, selfless work-but it ... Position Brand Description: The Associate Director - QA is a partner with the Sr. Director - QA in ...
... and managed, and support the communities we serve. This is hard, urgent, selfless work--but it ... Position Brand Description: The Associate Director - QA is a partner with the Sr. Director - QA in ...
... and managed, and support the communities we serve. This is hard, urgent, selfless work--but it ... Position Brand Description: The Associate Director - QA is a partner with the Sr. Director - QA in ...
... and managed, and support the communities we serve. This is hard, urgent, selfless work-but it ... Position Brand Description: The Associate Director - QA is a partner with the Sr. Director - QA in ...
... and managed, and support the communities we serve. This is hard, urgent, selfless work-but it ... Position Brand Description: The Associate Director - QA is a partner with the Sr. Director - QA in ...
Associate Director
Indianapolis, IN · On-site
$143K - $286K/yr
The Associate Director, Program Management is responsible for management of multiple programs for Carrier's North America Residential & Light Commercial HVAC business. Applicant must be capable of ...
Associate Director
Indianapolis, IN · On-site
$143K - $286K/yr
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This position is responsible for managing the packaging andawarding of financial aid, ensuring ... The Associate Director overseesthe development, implementation, and monitoring of office procedures ...
This position is responsible for managing the packaging andawarding of financial aid, ensuring ... The Associate Director overseesthe development, implementation, and monitoring of office procedures ...
This position is responsible for managing the packaging andawarding of financial aid, ensuring ... The Associate Director overseesthe development, implementation, and monitoring of office procedures ...
This position is responsible for managing the packaging andawarding of financial aid, ensuring ... The Associate Director overseesthe development, implementation, and monitoring of office procedures ...
This position is responsible for managing the packaging andawarding of financial aid, ensuring ... The Associate Director overseesthe development, implementation, and monitoring of office procedures ...
This position is responsible for managing the packaging andawarding of financial aid, ensuring ... The Associate Director overseesthe development, implementation, and monitoring of office procedures ...
This position is responsible for managing the packaging andawarding of financial aid, ensuring ... The Associate Director overseesthe development, implementation, and monitoring of office procedures ...
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Join us as an Associate Director Capital Project Management, where you will be responsible for the planning, design, and implementation of capital projects. This role is not just about managing ...
Join us as an Associate Director Capital Project Management, where you will be responsible for the planning, design, and implementation of capital projects. This role is not just about managing ...
Join us as an Associate Director Capital Project Management, where you will be responsible for the planning, design, and implementation of capital projects. This role is not just about managing ...
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Indianapolis, IN · On-site
The Associate Director - Technical Services / Manufacturing Science (TSMS) - API is responsible for ... Hire, manage, mentor, and develop a team of scientists and technical staff, fostering a culture of ...
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As an Associate Director Capital Project Management, you will lead, direct and manage cross-functional site and global project teams. You will comprehend strategic project requirements and translate ...
Join us as an Associate Director Capital Project Management, where you will be responsible for the planning, design, and implementation of capital projects. This role is not just about managing ...
Join us as an Associate Director Capital Project Management, where you will be responsible for the planning, design, and implementation of capital projects. This role is not just about managing ...
Join us as an Associate Director Capital Project Management, where you will be responsible for the planning, design, and implementation of capital projects. This role is not just about managing ...
Join us as an Associate Director Capital Project Management, where you will be responsible for the planning, design, and implementation of capital projects. This role is not just about managing ...
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The Associate Director, Residential Product Management is responsible for leading the strategic direction, roadmaps, new product development, portfolio lifecycle management, annual planning and ...
The Associate Director, Residential Product Management is responsible for leading the strategic direction, roadmaps, new product development, portfolio lifecycle management, annual planning and ...
The Associate Director, Residential Product Management is responsible for leading the strategic direction, roadmaps, new product development, portfolio lifecycle management, annual planning and ...
The Associate Director - Project Management delivers new and renovated capital assets for the Global Facilities Delivery (GFD) organization leading and managing teams that deliver large programs of ...
The Associate Director - Project Management delivers new and renovated capital assets for the Global Facilities Delivery (GFD) organization leading and managing teams that deliver large programs of ...
The Associate Director - Project Management delivers new and renovated capital assets for the Global Facilities Delivery (GFD) organization leading and managing teams that deliver large programs of ...
The Associate Director - Project Management delivers new and renovated capital assets for the Global Facilities Delivery (GFD) organization leading and managing teams that deliver large programs of ...
The Associate Director - Project Management delivers new and renovated capital assets for the Global Facilities Delivery (GFD) organization leading and managing teams that deliver large programs of ...
The Associate Director - Project Management delivers new and renovated capital assets for the Global Facilities Delivery (GFD) organization leading and managing teams that deliver large programs of ...
Associate Director Brand Management information

Associate Director - Global Regulatory Affairs - Product Communications
Indianapolis, IN • On-site
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 11 days ago
Eli Lilly and Company rating
8.9
Based on 64 frontline employees who took The Breakroom Quiz
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.)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).
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.
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About Eli Lilly
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Eli Lilly, based in Indianapolis, IN, US, is one of the pioneers in the pharmaceutical industry with a rich history dating back to 1876. This global pharmaceutical company focuses on discovering, developing, manufacturing and selling pharmaceutical products in approximately 120 countries. The company's product categories include endocrinology, oncology, cardiovascular, neuroscience, and immunology. Having invested over $9 billion in research and development in the past decade, Eli Lilly is also committed to creating high-quality medicines that meet real needs. As a recipient of several awards and recognitions, Eli Lilly is known for its focus on life-saving research and drug development. Their mission is to make medicines that help people live longer, healthier, and more active lives.
Industry
Pharmaceutical product wholesalers
Company size
10,000+ Employees
Headquarters location
Indianapolis, IN, US
Year founded
1876