Madrigalpharma
Document Control Associate II page is loaded## Document Control Associate IIlocations:
PA - Conshohocken - Officetime type:
Full timeposted on:
Posted 3 Days Agojob requisition id:
JR\_000509Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.**DESCRIPTION OF THE POSITION:**The Quality Assurance Document Control Associate II assists with the management, organization, and maintenance of all quality-related documentation within the organization. This role ensures that all documents meet regulatory standards and are easily accessible for audits and reviews. The position works closely with various departments to ensure that documentation practices comply with internal and external quality standards.**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.**Qualifications:**• 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)Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. The base salary range for this position is $87,000 - $107,000 per year.All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.
We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Applications are being accepted on an ongoing basis and can be submitted through our
site.
*Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text #J-18808-Ljbffr
PA - Conshohocken - Officetime type:
Full timeposted on:
Posted 3 Days Agojob requisition id:
JR\_000509Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.**DESCRIPTION OF THE POSITION:**The Quality Assurance Document Control Associate II assists with the management, organization, and maintenance of all quality-related documentation within the organization. This role ensures that all documents meet regulatory standards and are easily accessible for audits and reviews. The position works closely with various departments to ensure that documentation practices comply with internal and external quality standards.**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.**Qualifications:**• 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)Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. The base salary range for this position is $87,000 - $107,000 per year.All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.
We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Applications are being accepted on an ongoing basis and can be submitted through our
site.
*Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text #J-18808-Ljbffr