Eli Lilly

Associate - Labeling Implementation - North America

Eli Lilly • $63K — $149K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree required; preferably in scientific or health sciences field.
  • 3-5 years of experience in biotechnology or pharmaceutical industry.
  • Knowledge of local regulatory procedures and evolving reforms.
  • Understanding of manufacturing and supply chain practices.
  • Demonstrated skills in cross-functional leadership and influence.

Responsibilities

  • Lead and influence labeling-related activities to ensure compliance with regulatory timelines.
  • Monitor implementation of updated labeling components into the market.
  • Advise affiliates on managing labeling document integrity and control.
  • Liaise with cross-functional partners managing multiple concurrent labeling changes.
  • Oversee proof copy approval processes and interactions with Printed Packaging Development.
  • Train affiliates on labeling systems, tools, and operational processes.

Benefits

  • Comprehensive benefit program including medical, dental, and vision coverage.
  • 401(k) and pension plans available to full-time employees.
  • Flexible spending accounts for healthcare and dependent care expenses.
  • Life insurance and death benefits provided.
  • Opportunities for participation in employee assistance programs and wellness activities.
Full Job Description
The Associate - Global Regulatory Affairs (GRA) Labeling Implementation -North America drives the timely and high-quality implementation and maintenance of product labeling in the assigned country/region. This role develops collegial, mutually positive relationships across Regulatory, Printed Packaging Development (PPD), Manufacturing/Supply Chain, Global Packaging, Development, and other business partners. The Global Regulatory Affairs (GRA) Labeling Implementation utilizes regulatory labeling process expertise across the organization and geographies to drive consistency and influence effective change management.

Responsibilities

Labeling Implementation Leadership

  • Lead, partner, and influence labeling-related activities throughout the product lifecycle to drive timely and efficient implementation of labeling changes ensuring regulator and internal timelines are met.


  • Function as a delegate for Affiliate labeling implementation responsibilities outlined in the Labeling Development and Maintenance standard.


  • Lead and monitor the implementation of updated or new labeling components into the market.


  • Advise affiliates on responsibility for managing control and integrity of affiliate truth copy documents.


  • Liaise with cross functional partners to handle multiple changes occurring simultaneously (e.g., GRA-CMC or site technical changes impacting labeling).


  • Provide oversight for the proof copy approval process and interactions with PPD.


  • Train and assist affiliates on the use of systems, tools, and processes.


  • Act as a power user for key labeling systems such as BLUE, RIM, etc.


  • Assist with deviations, escalations, and audits related to labeling implementation.


  • Monitor new regulations and guidances for assigned country/region, assess impact with input from Regional Regulatory Scientists, Device Regulatory Scientists, and Labeling Process Owner, and track progress.


Functional and Technical Expertise

  • Maintain an understanding and expertise on local requirements, laws, and regulations related to labeling implementation.


  • Act as a subject matter authority and resource for other GRA colleagues (e.g., Regional Regulatory Scientists, Device Regulatory Scientists, Product Communication reviewers) on labeling processes.


  • Educate customers on regulatory requirements, roles / responsibilities, labeling best practices and the process to ensure timely implementation of new or revised labeling.


Decision Making/Influence/Problem Solving

  • Serve as a labeling resource for regulatory to develop and gain support for strategies and concepts that will deliver timely labeling for marketed products.


  • Apply knowledge of business processes and labeling to gain alignment with partners on standardized processes and labeling deliverables.


  • Process information and team dynamics and adapt a style when negotiating with cross functional partners to enable effective decision making and timely completion of deliverables.


Impact

  • Drive timely implementation of labeling changes ensuring regulatory and internal timelines are met.


  • Demonstrate understanding of labeling implementation process and understand impact. Communicate impact of labeling changes to cross-functional partners.


  • Collaborate with Regulatory team on submission and implementation plans to capitalize upon opportunities for bundling changes for more efficient implementation, when applicable.


Customer / External Focus

  • Routinely share labeling knowledge with key customers. Participate in internal working groups to make recommendations that may shape regulatory labeling environment.


  • Identify appropriate customers and partners to communicate impact of labeling changes. Anticipate questions and proactively communicate possible impact to labeling.


Basic Qualifications

  • Bachelor's degree
  • 3-5 years in the biotechnology or pharmaceutical industry
  • 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 Preferences/Other Information

  • Scientific or health sciences degree field preferred (or equivalent work experience)


  • Knowledge of local regulatory procedures and practices and awareness of evolving regulatory reform


  • Understanding of manufacturing and supply chain practices


  • Knowledge of drug development


  • Project management experience


  • Demonstrated ability to lead, influence and partner cross-functionally


  • Demonstrated capability for contributing on complex projects with accelerated timelines


  • Demonstrated strong communication skills: writing, presenting, listening.


  • Shown flexibility to handle multiple tasks simultaneously


  • Proven competence of computer skills (e.g., Word, Excel, PowerPoint)


  • Demonstrated agility to learn new computer systems and tools, attention to detail and organizational skills, and ability to work independently


  • Demonstrated effective teamwork abilities, adaptability to diverse interpersonal styles, and problem-solving skills


Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $149,600

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.

#WeAreLilly

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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