Trial Master File (TMF) SpecialistLocation San Rafael, California Apply
Department / Cost Center:
Development Sciences Quality
Reports to (Job Title):
Sr. Director, Development Sciences Quality
January 26, 2020
OVERVIEW:Development Sciences Quality (DSQ)
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, eTMF and records management, inspection readiness and response support and training development and delivery.
The Specialist is responsible for actively supporting the Development Sciences Quality organization in the areas of Trial Master File (TMF) Management and Quality. The Specialist achieves this through oversight of the documents filed to the eTMF,quality review and quality control of documents, reviewing trends and/or metrics gathered from the eTMF and providing guidance and recommendations to the study teams on best TMF management practices including resolving issues, review organization of documents to ensure completeness andfacilitating retrieval during audits and inspections.
The Specialist has foundational skills in Planning, Teamwork, Proactivity, Communication, and Problem Solving. The specialist should exhibit foundational skills in Regulations and Good Practices and Quality Management while developing technical skills in Process Analysis and Change Management.
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. This includes:
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:
BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway in DSQ has been defined and is available to employees of BioMarin.
No people management responsibilities.
EDUCATION AND EXPERIENCE
WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Computer work utilizing common business software programs.
Internal: Clinical Operations; Data Management; Pharmacovigilance; Medical Writing; Clinical Sciences; Pharmaceutical Sciences; Corporate GxP Compliance; Regulatory Affairs; TechOps Quality; Legal; Project Management; Computer System Validation Quality; IT.
External: CROs; other clinical vendors and suppliers