Manager/Senior Manager, Global Artwork Management

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare liver diseases. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. Learn more about our work, our culture, and what it’s like to be a part of our team:

Position Summary

The Senior Manager/Manager, Global Artwork Management, will provides oversight for all aspects of Mirum’s Global Artwork & Labeling end-to-end process and systems, including metrics, tracking and documentation.

This is a highly integrated role that will work cross-functionally partnering with Mirum’s internal functions/SMEs (Supply Chain Market Leads, Global Labeling, Global Regulatory, GMP Quality, CMC, Analytical Testing, Commercial functions in the US, Canada, and International) and external partners (Graphic Artwork Suppliers and PCI Global Sites) to develop pristine and compliant product artwork aligned with our approved global labeling and adhering to regulations across the worldwide health authorities/agencies.

Job Functions/Responsibilities

Responsible for developing and executing effective quality control reviews and tracking (primarily) of internal labeling documents and outward facing local/regional labeling, to meet regional regulatory requirements and ensure consistency between labeling, labels, and supportive documents. Supports labeling inspection/audit readiness activities. Demonstrates understanding of labeling requirements, regulations, and guidance in support of labeling strategies worldwide. Contributes to the continuous improvement of the end-to-end labeling process and supports labeling inspection / audit readiness activities. Supports new market introductions, product launches and label variations.

• Ensure labeling is in accordance with all current regional regulatory regulation, guidance and requirements.
• Follows and formulates improvements to labeling policies, processes, quality, and system tools.
• Track all labeling changes, implementation, and deviations for assigned regions
• Support labeling inspection/audit readiness activities
• Manage and maintain labeling documents in document management systems; Manage label review and approval
• May be assigned additional responsibilities, as deemed necessary
• Oversight of global distribution, tracking, and reporting of approved labeling and labeling updates.
• Partner with external service providers (e.g., artwork studio, Contract Manufacturers)
• Collaborate with global Mirum colleagues, Mirum affiliates and external partners, as needed.
• Evaluate and monitor compliance metrics for end-to-end labeling process
• Manage and maintain Change Control records in support of labeling activities
• Develop and report metrics and dashboards to support GL compliance oversight
• Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.
• Determine, evaluate, and investigate quality events, conduct root cause analyses and develop CAPA plans
• Act as subject matter expert when a new labeling technology and/or system is being evaluated
• Contribute to the continuous improvement of the end-to-end labeling process, including excellent proofreading / editing skills and compiling supportive documentation
• Partner with Regulatory Affairs to ensure that all labeling is submission ready and available for publishing

Qualifications

Education/Experience:

• Experience in project management
• >5 years of relevant experience in pharmaceutical labeling environment
• BS in Pharmaceutical / Biotech sector

Knowledge, Skills And Abilities

• Strong written and oral communication and organizational skills
• Understanding of pharmaceutical global labeling and artwork requirements and industry practice
• Ability to generate problem solving innovative solutions
• Attention to detail
• Solid understanding of the structure of the product labeling
• Solid understanding of requirements for tracking of labeling updates

The salary range for this position is $125,000 to $150,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

• For US Applicants Only: Mirum Pharmaceuticals is also committed to the safety and wellbeing of all who work with us. As we continue to monitor the COVID-19 pandemic, Mirum Pharmaceuticals has made the decision to require all perspective candidates and independent contractors in the United States to be fully vaccinated against the COVID-19 virus. To be considered fully vaccinated is to have both doses of a two-dose vaccine two weeks apart or two weeks since a single-dose vaccine has been administered. This does not apply to candidates/independent contractors who are granted an accommodation/exemption by Mirum Pharmaceuticals based on qualifying religious or medical reasons.