Madrigal Pharmaceuticals · 1 day ago
Document Control Associate II
Conshohocken, PA
Full-time
Onsite
Mid Level
$87K/yr - $107K/yr
3+ years expMadrigal Pharmaceuticals is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH). The Document Control Associate II will assist with managing and maintaining quality-related documentation, ensuring compliance with regulatory standards and supporting various departments in documentation practices.
BiopharmaBiotechnologyMedical DevicePharmaceutical
Responsibilities
Maintain all documents related to the manufacturing processes, including but not limited to executed batch records and Certificates of Analysis, within the EDMS
Create batches within the electronic Quality Management System (QMS) and track and upload documents required for batch disposition
Upload external documents to the EDMS for archival
Follow policies, SOPs, and work instructions to support the document change control process, assign effective dates and training workflows, and archive documents
Individual may assist in developing, managing, and maintaining Madrigal Standard Operating Procedures (SOPs), work instructions, protocols, and policies
Participate in periodic reviews of documents within the electronic document system to ensure formatting complies with current templates
Manage document lifecycle, including creation, revision, approval, distribution, and archiving
Assist with the creation of document control metrics, reports and dashboards
Work in preparing and organizing documentation for internal and external audits
Assist users with document related activities in the EDMS
Assist departments with offsite archival of documents and maintain full traceability
Maintain confidentiality and security of all documents and information
Communicate effectively with team members and management to provide updates on document control activities
Manages internal quality improvement initiatives: evaluate internal processes, and suggest/design/implement improvements
Provides clerical and administrative support related to documentation processes and systems to include reviewing for conformance to document templates and format
Pre-approves and routes documents for review and approval in Veeva QualityDocs
Responsible for filing and maintenance of GxP controlled documents and records. Ensures files are accurate and easily retrievable
Provides additional support and assistance on tasks and projects as directed by management
Operates as an effective liaison to internal corporate cross-functional areas, CMC/QA consultants, and external partners/contractors
Participate in quality improvement initiatives and projects
Stay updated on industry best practices and regulatory changes related to quality assurance documentation and maintain required knowledge of applicable regulations, guidelines, and company standards and procedures
Qualification
Required
BS/BA, with 3-5 years' experience, preferably in pharmaceutical and/or biotech environment in document control and management
Experience with Veeva specifically Quality Docs, Training and QMS modules
Proficiency in MS Word, Excel, Power Point, and DocuSign Part 11
Candidate will have knowledge of GXPs, especially Good Documentation Practices and a good understanding of GMPs
Excellent organizational and time management skills
Strong attention to detail and accuracy
Effective communication and interpersonal skills
Knowledge and experience in development, and/or reviews of policies and procedures (i.e., policy documents and SOPs)
Benefits
Flexible paid time off
Medical, dental, vision and life/disability insurance
401(k) offerings (i.e., traditional, Roth, and employer match)
Additional voluntary benefits like supplemental life insurance, legal services, and other offerings
Mental health benefits through our Employee Assistance Program for employees and their family
Company
Madrigal Pharmaceuticals
Madrigal Pharmaceuticals is a biopharmaceutical company developing therapeutics for the treatment of cardiovascular-metabolic diseases.
501-1000 employees
H1B Sponsorship
Madrigal Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.94BKey Investors
Blue OwlHercules Capital
2025-07-22Post Ipo Debt· $350M
2024-03-18Post Ipo Equity· $690M
2023-09-28Post Ipo Equity· $500M
Leadership Team
Mardi C. Dier
Chief Financial Officer
Carole Huntsman
Chief Commercial Officer (CCO)
Recent News
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2026-01-07
2026-01-06
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2026-01-03
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