Associate / Senior Associate - Clinical Trial Label Management

3+ years

Not Disclosed

Cork

10 Jan. 29, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate / Senior Associate - Clinical Trial Label Management
Location: Cork, Ireland
Category: Research & Development
Job Type: Full Time, Regular
Job ID: R-78815

Company Overview:
At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader, our employees work to bring life-changing medicines to those who need them and improve the understanding and management of diseases. We value our workforce and encourage internal development, offering opportunities for growth and progression within the company.

Eli Lilly Cork is a diverse team of over 1,600 employees from 38 nationalities, delivering innovative solutions across various business services, including Finance, IT, Medical, and Clinical Trials. We offer a premium workspace in Little Island, Cork, with benefits such as flexible hybrid working, healthcare, pension, life assurance, subsidized canteen, onsite gym, travel subsidies, and more.

We are committed to diversity, equity, and inclusion (DEI), ensuring the inclusion of all backgrounds, abilities, genders, and cultures.

Position Overview:
The Clinical Trial Label Management Associate/Senior Associate will leverage their technical expertise to accurately create investigational product (IP) labels that align with study requirements and comply with regulatory standards. This role ensures on-time delivery and high-quality production of labels by collaborating with Clinical Supply and Delivery teams, reviewing protocols, and maintaining consistency in label text across trials.

Key Responsibilities:

Label Creation & Submission:
- Create and submit label requests, ensuring labels meet clinical trial needs and regulatory requirements.
- Develop label text based on study protocols and packaging designs.
- Collaborate with internal and external partners to ensure timely and compliant label delivery.
Collaboration & Communication:
- Work closely with Supply Planning, Label Project Coordinators, Packaging Operations, Clinical Development, third-party vendors, and global affiliates to ensure effective label creation.
- Provide label expertise and track progress of label requests, ensuring they align with packaging timelines.
- Propose and introduce new phrases to Lilly’s label phrase library to improve consistency.
Process Improvement & Optimization:
- Identify opportunities for improvement in the label creation and approval process to reduce costs, minimize risks, and accelerate timelines.
- Participate in and support process improvement initiatives related to the labeling process.
- Stay up to date with cGMPs, GCPs, and other regulatory requirements, ensuring all activities adhere to industry standards.
Quality & Compliance:
- Ensure adherence to all applicable regulatory requirements, including GMP and GCP regulations.
- Prevent issues through proactive planning and educational outreach to stakeholders.
Additional Responsibilities:
- Mentor junior Label Management Associates, providing guidance and training.
- Collect and report metrics to measure performance and optimize efficiency.
- Participate in special projects and periodic reviews as required.

Educational Requirements:

A four-year degree in a pharmacy, health-related, scientific, or engineering field (or equivalent work experience).

Experience & Skills Requirements:

Minimum Experience:
- 3+ years of experience in Clinical Supply and Delivery or a related clinical role.
Technical Skills:
- Ability to translate study protocol elements and packaging design into clear, accurate label text.
- Strong attention to detail and record of high-quality performance.
- Solid understanding of GCP regulations, GMP requirements, and clinical trial processes.
- Proficiency with Microsoft Office and other relevant software.
Communication & Collaboration:
- Strong written and verbal communication skills.
- Ability to influence and collaborate across teams, management levels, and external partners.
- Effective at building professional relationships and networks.

Preferred Qualifications:

Knowledge and experience working with Quality Assurance in regulated environments.
Experience within the pharmaceutical industry is highly beneficial.
Fluent in English; additional language skills are a plus.

Other Information:

Travel: Limited travel may be required.
Diversity & Inclusion: Lilly is committed to creating an inclusive work environment. We encourage applicants from diverse backgrounds to apply.

Lilly is dedicated to supporting individuals with disabilities by offering accommodations during the application process. Please reach out if you require assistance.

If you're passionate about delivering quality clinical trial solutions and are ready to work in a dynamic, supportive environment, apply today!

#WeAreLilly

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Associate / Senior Associate - Clinical Trial Label Management

Job Description

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