Pharmaceutical Label Specialist

Keyrus Life Science North America; Philadelphia, Collegeville (Philadelphia County, PA); On-site; USD 70,000 - 80,000; Full time

Job summary

An established industry player is seeking an External Label Specialist to join their Global Pack Management Team. This role involves creating and approving label content for clinical trials across various modalities, including vaccines and pharmaceuticals. You will collaborate with third-party manufacturers, ensuring compliance with regulatory requirements while maintaining high-quality standards. This position offers the chance to work in a dynamic environment, where you can contribute to meaningful projects and enhance your skills. If you have a background in GMP and a passion for quality, this opportunity could be your next career step.

Benefits

Comprehensive integration program

Training opportunities

Competitive salary package

Pension plan

Health insurance

Qualifications

• 3-5 years of relevant experience in GMP and labeling.
• Proficient in using Microsoft Office and Adobe tools.

Responsibilities

• Create and approve label content for clinical trial supplies.
• Liaise with third-party manufacturers for label production.
• Perform quality checks on label content across languages.

Skills

GMP experience

pack and label experience

Microsoft Office proficiency

Adobe tools proficiency

strong communication skills

detail-oriented

experience in cross-cultural environments

Education

Background in computer or scientific training

Tools

SMART LS

Prisym

Job description

Job Description

The Global Pack Management (GPM) Team within Clinical Supply Chain Packaging Operations is responsible for:

1. The creation and sourcing of secondary packaging components for all products to be packaged internally within Sponsor’s clinical trial arena.
2. The management and control of all label content regulatory requirements and translations within the SMART LS label creation system for all countries/languages where clinical trials are conducted.
3. The creation and approval of all label content for clinical trial labels across multiple modalities, liaising with over 60 countries globally, and interfacing with Sponsor’s Clinical Interface/CTSM team to determine delivery timescales.

This role is specifically recruiting for an External Label Specialist within GPM, tasked with the creation and approval of label content for third parties for the following modalities:

• Vaccines
• Pharmaceuticals (supplies packed externally to Sponsor)

The External Label Specialist will liaise with Clinical Interface/CTSM teams to create label content and coordinate with multiple third-party manufacturing/packaging companies to produce and approve the final clinical trial labels, using Sponsor systems such as SMART LS and Prisym.

The approved labels will be used for labeling clinical trial supplies packaged at third parties. Additionally, there will be opportunities to cross-train in other areas within GPM.

This position works within a global team and involves responsibilities such as:

1. Creating master label content according to established processes specific to each modality.
2. Liaising with third-party contract manufacturing/packaging companies to provide label content and receiving labels created by third parties.
3. Performing quality checks of label content in various languages within required timelines.
4. Creating label documentation for in-country regulatory submissions.
5. Managing translations within SMART LS and liaising with translation providers.
6. Identifying opportunities for process improvement.
7. Ensuring quality and compliance across all elements of label creation.
8. Participating in quality investigations and implementing CAPAs.
9. Working independently to prioritize and complete tasks.
10. Collaborating with external vendors and participating in department improvement projects.
11. Liaising with other groups within Clinical Supply Chain, such as Clinical Interface/CTSM and QA.

Competencies:

• Understanding of cGMP and regulatory requirements.
• Proficiency in Microsoft Office and Adobe tools.
• Ability to work across multiple GMP IT systems and adapt to changing systems.
• Strong communication skills, both verbal and written.
• Ability to work independently and as part of a team.
• Detail-oriented with a focus on high-quality output.
• Experience working in a cross-cultural environment.

Must have:

• GMP experience, pack and label experience, proficiency with computer systems, error detection, document comparison, and procedure following. Must be able to work onsite in Collegeville, Philadelphia.
• Minimum 3-5 years of relevant experience.

Education:

Background in computer or scientific training.

Compensation:

Full benefits package; salary between $70,000 to $80,000.

What we offer:

At Keyrus, employees receive a comprehensive integration program, training opportunities, and a competitive salary package including benefits such as pension and health insurance.

Who we are:

Keyrus Life Science is an international provider of consulting and services in clinical research, committed to transparency, integrity, and excellence. We focus on delivering high-quality services with a human touch across various stages of drug development.