Senior Specialist, Trial Master File
Category: Research & Development | Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4186
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
Responsible for the maintenance of Trial Master File related records and documents, including but not limited to receiving, reviewing, indexing, scanning, filing, to ensure compliance with relevant regulatory regulations, internal standard operating procedures, and industry standards surrounding the Trial Master File. Assist in training and mentoring of staff in the TMF Group.
This role does not offer relocation.
- Participates in the review, filing, archival, tracking and retrieval processes for TMF related documents stored on or off site.
- Maintains integrity of internal Jazz TMF storage area (room access, closure, temperature/humidity, etc.) and orchestrates off-site storage processes (if applicable).
- Resolves TMF document requests and assists in resolving documentation issues with other Functional Representatives.
- Participates in the TMF Group efforts in preparing for and participating in audits and/or regulatory inspections.
- Support internal and external audits including development and implementation of CAPA results and activities
- Supports the implementation and management of electronic TMF system.
- Supports the creation and executing of eTMF training and access
- Supports the management of Trial Master File records life cycle, including retention and disposition of records and associated audit trails in accordance with best business practices, applicable regulations and corporate policies and procedures
- Supports the transition of proprietary information for acquisitions, divestitures and licensing of compounds related to trial master file records
- Supports the maintenance of TMF Index
- Assists in Training and Mentoring of new staff and Contractors
- Supports other TMF projects as needed
Required Knowledge, Skills, and Abilities
- Experience in Trial Master File requirements and set-up
- Knowledge of DIA filing structure
- Knowledge of global regulatory requirements and ICH/GCP guidelines
- Working knowledge with electronic document management systems and document archival systems (eTMF)
- Demonstrated ability to work independently and in a team environment across multiple time zones
- Strong organizational abilities, action oriented and strong communication skills
- Able to carry out responsibilities with minimal to no supervision
- Knowledge of document management processes and procedures, electronic documentation systems, data retrieval, and electronic file formats
- Ability to demonstrate initiative.
- Ability to plan and organize work in an efficient manner, and work well under time constraints.
Required/Preferred Education and Licenses
- Bachelor Degree & minimum of 3 years directly related experience Clinical Trials, TMF and clinical systems and process, OR
- A minimum of 5 or more years’ experience in the Pharmaceutical Industry with at least 3 years direct experience in Clinical Trials, TMF and clinical systems and process
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Visio, Outlook)
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
- Occasional moving, packing, and/or lifting of TMF documents for archival purposes
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action 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 characteristic protected by law.