Sr. Associate: Labelling

Job Description

The Labeling Specialist will play a crucial role in ensuring that Amgen's labeling processes comply with global regulatory requirements while maintaining the highest standards of quality. You will work in a fast-paced, matrixed environment, collaborating extensively with cross-functional teams, including Regulatory Affairs, Quality, Operations, and Supply Chain, to ensure the successful execution of labeling initiatives. This role offers the opportunity to lead initiatives, drive continuous improvement, and contribute strategically while working across multiple regions and functions.

Key Responsibilities:

1. Labeling Strategy and Execution

- Coordinate and manage day-to-day labeling activities to ensure that updates are made in a timely manner and in compliance with global regulatory requirements.
- Act as the primary contact for cross-functional teams, offering guidance and support on labeling procedures, formats, and timelines.
- Execute labeling change requests, ensuring progress is tracked and accurate documentation is maintained in labeling management systems.

2. Cross-Functional Collaboration in a Matrix Organization

- Collaborate with global and regional stakeholders (Regulatory Affairs, Quality, Operations, Supply Chain) to streamline labeling processes and ensure alignment across multiple time zones.
- Identify and escalate potential compliance risks or delays, partnering with teams to resolve issues promptly.
- Engage proactively with global affiliates to collect requirements, clarify expectations, and implement labeling changes seamlessly.

3. Process Improvement and Compliance

- Contribute to continuous improvement initiatives, optimizing labeling processes, templates, and workflows to improve efficiency and compliance.
- Support the maintenance of inspection readiness by ensuring documentation, SOPs, and labeling processes align with quality standards and internal policies.
- Collect and analyze data on labeling operations, recommending improvements to enhance transparency, speed, and accuracy.

4. Stakeholder and Vendor Coordination

- Collaborate with external vendors (e.g., translation services, artwork vendors) to ensure adherence to quality and timeline requirements.
- Monitor vendor performance against established SLAs, promptly addressing any issues or gaps with internal teams.
- Participate in regular meetings with internal and external stakeholders to align on project deliverables, overcome challenges, and ensure timely completion of milestones.

5. Training and Knowledge Sharing

- Provide guidance and operational support to junior staff and peers regarding labeling compliance, best practices, and quality standards.
- Help develop or refine training materials and job aids to ensure consistent understanding and application of labeling procedures.
- Stay updated on emerging regulatory requirements and industry trends, sharing insights to influence labeling strategies.

Basic Qualifications:

- Doctorate degree OR
- Master's degree with 2 to 4 years of directly related experience, OR
- Bachelor's degree with 4 to 6 years of directly related experience, OR
- Diploma with 8 to 10 years of directly related experience.

Note: Equivalent combinations of education and experience will be considered.

Preferred Qualifications:

- Experience with labeling management systems (e.g., Veeva Vault) or other document management platforms.
- Familiarity with global labeling regulations and end-to-end labeling processes.
- Demonstrated ability to plan and manage projects in a matrixed environment while meeting deadlines and managing multiple priorities.
- Strong collaboration and communication skills, with experience working with international teams across different time zones.
- Proven problem-solving capabilities and an analytical mindset, with a keen attention to detail.
- Experience in vendor coordination, ensuring quality and compliance with established performance metrics.

What We Offer:

- Opportunity to play a key role in a highly visible and impactful regulatory submission process.
- A collaborative and dynamic work environment with cross-functional and global teams.
- Competitive salary, comprehensive benefits, and flexible work models.
- A focus on professional growth and continuous improvement.

---