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Sr Specialist - Trial Master File

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.

Sr Specialist – Trial Master File

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.

Summary Description:

The Sr. Specialist has subject matter expertise within the Development Sciences Quality organization in one or more areas: Quality Operations, Controlled Document Management, or Trial Master File (TMF) Quality and Records Management. For example, the Sr. Specialist may be involved in Standard Operation Procedure (SOP) deviation management and tracking, corrective and preventative action (CAPA) plans, data integrity plans, SOP documentation or training development. The Sr. Specialist acts with significant independence and may be involved in more than one DSQ area.

The Sr. Specialist has foundational skills in Influencing and Leadership, and demonstrates advanced Teamwork skills. S/he has foundational abilities in all DSQ technical competencies, including Quality Management and Change Management.

Key Responsibilities:

eTMF Management

  • Facilitate the creation of the enterprise and study specific TMF management tools
  • Maintain TMF Management Plans and TMF Content Lists for complex studies; 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
  • Manage 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

Comprehensive Review

  • Conduct quality review of the TMF for each assigned study on an annual basis per the time points captured in the study-specific TMF Plan.
  • Establish any corrective actions which must be addressed and assigned
  • Submit documented evidence of the TMF Quality Review to the TMF
  • Manage TMF documentation issues throughout the lifecycle of an assigned study

Records Management

  • 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

o     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
  • Monitor and moderate access to Development Sciences records per the Records Management SOP, verifying that the processes for the management and archiving of Development Sciences records are compliant with relevant regulations
  • Effectively and efficiently archive GLP and GCP records and related information from the Development Sciences organization
  • Verify cross-functional alignment regarding records retention schedules and records disposition and destruction
  • Work with BioMarin Facilities Operations to manage business continuity procedures, environmental controls, DevSci Central Records Room security, disaster preparedness and disaster recovery

Competencies overview:

Individuals in the Sr. Specialist position are expected to demonstrate foundational Communication, Leadership, Proactivity and Problem Solving skills and advanced Teamwork skills, including:

  • actively contributing to team definition of goals, roles and tasks
  • proactively expanding one’s network and work relationships outside the department
  • ability to create inclusive and collaborative team and meeting environments
  • ability to recognize, articulate and prioritize key issues that arise based on understanding of objectives
  • ability to analyze and evaluate problems and seek out and recommend possible solutions
  • leveraging data effectively to communicate points of view and influence outcomes

The Sr. Specialist should demonstrate foundational skills in all DSQ technical competencies, including Process Analysis, Change Management, and Training Management. Capabilities include:

  • an ability to identify bottlenecks or inefficiencies in a process, as well as consumer needs, and alert the appropriate stakeholders
  • an ability to support change management processes by ensuring buy-in, readiness, and understanding among participants and stakeholders
  • an ability to organize and prioritize training communications content, ensuring inclusion of essential material while maintaining brevity where needed

Education and Experience:

  • BA/BS in life sciences or technical area; experience in lieu of education may be considered
  • 4+ 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

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.

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