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Sr. Trial Master File Specialist (TEMPORARY)

Location San Rafael, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives. 

Duties


The Development Sciences Quality (DSQ) group is focused on partnering with Development Sciences functional groups, project teams and study teams to proactively promote, facilitate and verify the implementation of, and adherence to, good quality practices across the drug development lifecycle in order to be inspection ready at all times. DSQ achieves this by implementing, maintaining and continuously improving a quality management system which includes robust quality operations oversight, controlled document management, TMF and records management, inspection readiness and response support and training development and delivery. 


As part of DSQ, the Development Sciences Records Management (DSRM) team focuses on TMF and records management. The Sr. TMF Specialist is responsible for actively supporting the Development Sciences Quality organization in Trial Master File (TMF) for both paper and electronic documents. The Sr. TMF Specialist will have responsibility for management of a group of studies in a specific therapeutic area, maintaining an inspection ready TMF through daily document processing, monthly missing document identification and quarterly QA.



The Sr. TMF Specialist has solid skills in Planning, Teamwork, Proactivity, Communication, and Problem Solving. He or she should also exhibit solid skills in Regulations and Good Practices and Quality Management. The Sr. TMF Specialist has the ability to evaluate the health of an entire TMF on an ongoing basis.

Skills


TMF Processing and Management



    • Maintain and work to TMF Study Plans and Content Lists

    • Process documentation submitted to TMF in a timely and accurate manner

    • Partner with core and extended study teams to support timely submission as well as correction of documentation to the TMF.

    • Provide one-on-one support and/or guidance to submitters, when needed.

    • Generate and provide documentation metrics, as needed.

    • Update Missing Document Dashboards on an ongoing basis and assist with preparing monthly snapshots to be distributed to study teams.

    • Participate in the quarterly QA of paper and/or electronic TMF documentation Assist with special projects, as needed



TMF-Related Collaboration & Support



    • Participate in DSRM meetings and provide TMF status updates, as needed

    • Maintain awareness of study events and the associated documentation requirements, where possible


    • Assist with study close-out activities related to TMF



        • Support the DSRM team with TMF document retrieval during Audits and Inspections

        • Support the management of TMF documentation issues throughout the lifecycle of an assigned study



      Quarterly Quality Assurance Review



        • Conduct QA document review of the TMF for each assigned study on a quarterly basis as needed.

        • Identify any corrective actions which must be addressed and assigned

        • Create documented evidence of the TMF Quarterly Quality Assurance Review to the TMF

        • Create and maintain Missing Document Dashboards as part of the TMF Quarterly QA Review to ensure completeness of the TMF



      Records Management



        • Participate in or lead TMF Process Improvement activities as needed.

        • Support and follow processes associated with receiving, QC’ing, classifying, indexing, approving, correcting, scanning and storing TMF documents

        • Process TMF documents in compliance with DSRM and all applicable SOPs and WIs

        • Provide guidance on best practices for document handling, retrieval and archival procedures

        • Respond to internal and/or external document information inquiries related to DSRM documents


      Systems Development



        • Participate in the development, implementation, and maintenance of classification and filing systems per administrative, research, regulatory, legal and financial requirements

        • Manage off-site storage of DSRM documents, if needed

        • Participate in the development, implementation, and maintenance of internal databases used to manage documents



Education


Competancies: Overview



    • Individuals in this role are expected to demonstrate solid Communication, Problem Solving, Planning, Prioritization and Organization, Proactivity, and Teamwork skills in order to quickly integrate into the BioMarin team-based, cross-functional culture. This includes:



        • Sharing ideas and work product with competence in a clear, concise, and timely way effectively facilitating small functional meetings.

        • Adeptly identify critical path tasks and consistently deliver on time and as expected

        • Developing and maintaining strong working relationships

        • Modeling a fair, transparent and collaborative approach to work execution


      The Sr. TMF Specialist will also must have excellent time management and project management skills as well as be able to work independently and proactively.





    • HS Diploma required with a BA/BS in life sciences or technical area preferred; experience in lieu of education will be considered


    • 2+ years TMF experience

Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

San Rafael

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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