770 Lindaro St San Rafael, CA 94901
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- Facilitate the creation of the enterprise and study specific TMF management tools
- Maintain TMF Management Plans and TMF Content Lists
- Work with the Study Teams to check and verify the plans and communicate the importance of each document to the Study Team based on risk level
- Coordinate creation of the TMF filing locations within BioMarin based on the study specific TMF Content List
- Participate in the Quality Control of documents (paper and electronic) submitted to the TMF or eTMF
- Facilitate the review and submission of TMF records to Records Management personnel
TMF-Related Collaboration & Support
- Support the coordination of the transfer of study-specific trial master files from the CRO
- Participate in Study Team meetings and provide/present regular TMF metrics updates
- Maintain awareness of study events and the associated documentation requirements through collaboration with Study Team
- Support Study Teams and designated Study Team Content owners in understanding their TMF-related responsibilities, requirements and expectations; act as an ad-hoc member of the Study Team Act as point person for Study Team TMF questions and manage close-out of TMF related issues in adherence to BioMarin processes
- Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
- Manage the TMF content list and TMF Comprehensive Review tracker
- Provide TMF metrics: completeness and quality of TMF documentation and content, including the percent completeness and the risk level of outstanding items on a periodic basis or as requested by DevSci management
- Participate in the conduct of quality review of the TMF for each assigned study on an annual basis per the time points captured in the study-specific TMF Plan.
- Identify any corrective actions which must be addressed and assigned
- Support the submission of documented evidence of the TMF Quality Review to the TMF
- Support the management of TMF documentation issues throughout the lifecycle of an assigned study
- Participate in the implementation of standards and processes for DevSci records management to verify compliance with relevant regulations
- Support and carry out the processes associated with the storing, archiving, indexing, scanning and classifying records:
- Process records (e.g., track, scan, archive) in compliance with DevSci Records SOPs
- Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records in DevSci Records
- Provide guidance on best practices for record handling, retrieval and archival procedures
- Provide archived DevSci records to users (e.g. internal staff and/or Auditors) for review.
- Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits Respond to TMF and non-TMF internal and/or external information inquiries related to DevSci records
- Participate in the development, implementation, and maintenance of classification and filing systems per administrative, research, regulatory, legal and financial requirements
- Manage the off-site storage of DevSci records and the contract with the storage vendor, including vendor oversight
- Participate in the development, implementation, and maintenance of internal databases used to manage records
- Individuals in this role are expected to demonstrate good foundational Communication, Problem Solving, Planning, Prioritization and Organization, Proactivity, and Teamwork skills in order to quickly integrate into the BioMarin team-based, cross-functional culture.
- sharing ideas and work product with competence in a clear, concise, and timely way effectively facilitating small functional meetings adeptly identifying critical path tasks and consistently delivering on time and as expected developing and maintaining strong working relationships modeling a fair, transparent and collaborative approach to work execution
- The Specialist will also focus on developing skills in the Leadership and Influencing and Persuasion competency areas.
- The Specialist is expected to demonstrate foundational technical skills in Regulations and Good Practices, as well as Quality Management. Skills should include:
- an understanding of key regulatory agencies and regulatory inspection processes
- an understanding of the objectives/purpose and key milestones/filings of each drug development phase (Pre-Clinical, phases I-IV)
- an understanding of GxP principles, their importance, and how they apply to operational activities currently being performed
EDUCATION AND EXPERIENCE
- BA/BS in life sciences or technical area; experience in lieu of education may be considered
- 2+ years of relevant pharmaceutical industry experience
- Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification a plus