Document Management Associate

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: www.mirumpharma.com.

POSITION SUMMARY

This position works within Technical Operations (Tech Ops) to support Chemistry, Manufacturing and Controls (CMC) and Clinical Supply Chain (CSC) Team members and the activities of the entire Technical Operations Functional Group (Analytical Development, CMC, Drug Substance Manufacturing, Drug Product Manufacturing, CMC Project Management, CMC Quality Control, Technical Operations and Clinical Supply Chain) in day-to-day operations, Document Management and technical assistance.

JOB FUNCTIONS/RESPONSIBILITIES

• Responsible for the management of GMP documents for Tech Ops Functional Group’s projects, including initial document type set-up, metadata tags, document creation, workflows, index and tracking, lifecycle updates and archive project GxP documentation in Veeva Quality Docs System and other document repositories.
• Provide direct and indirect support to Tech Ops SMEs with program activities, facilitating day-to-day operations and documentation tracking. Support may include facilitating program checklists, shipping logistics & shipping documentation, and electronic file organization.
• Support Tech Ops Functional Group with participation in internal and external audit and inspection activities including mock audit and inspection preparedness with Quality Assurance.
• Provide support and facilitate CMC Functional Group with shipping of R&D material (including raw materials, drug substance and drug product), tracking shipment and providing required documentation to ensure timely shipping and receipt of material. This includes working closely with SME to ensure compliance with US Customs and FDA Shipping laws and maintaining archive of shipping documentation.
• Assist CSC SMEs with clinical ancillary supplies orders received from CMO production facility to the CRO lab and test facility. Support CSC with purchase order process. Work with CSC and vendor to ensure supplies are safely shipped to intended destination.

QUALIFICATIONS

Education/Experience:

• Bachelor’s degree in science field or at least 4 years related experience.
• Advanced proficiency with Electronic Document Management System(s).
• Experience with Veeva Systems.
• Experience editing and formatting documents and various technical documents per established procedures.

Knowledge, Skills and Abilities:

• Excellent verbal and written communication skills; must be an effective communicator with strong interpersonal skills.
• Knowledge and understanding of GxP and industry standards.
• Experience with shipment & logistics management would be an asset.
• Familiarity with CMC processes sufficient to identify document types and create metadata tags.
• Ability to work independently or cross-functionally, dependent on the project needs.
• Ability to work on multiple projects and adapt to current team and company priorities.
• Advanced proficiency in computer skills including Microsoft Word, Excel, PowerPoint, Visio, Adobe Acrobat and Veeva.

#LI-Hybrid

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.

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