Temporary, Clinical Document Specialist
Why Join Us?
To be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to bringing to patients novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
ultrafocused – Work together to fearlessly uncover new possibilities
This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Ultragenyx's Standard Operating Procedures (SOPs) as appropriate. The Temporary Clinical Document Specialist will provide support to the TMF content owners on one or more clinical programs. This position will work closely with the Study Management Teams (SMT) to ensure that the TMF is kept both current and inspection ready according to Ultragenyx SOPs and applicable regulations.
Responsibilities including, but not limited to:
- Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF
- Review and classify documents collected from internal and external sources
- Create, maintain, review, and archive hardcopy TMF
- Reconcile essential documents in both hard/soft copies to avoid duplication
- Perform QC and maintenance of eTMF/TMF for assigned studies
- Perform data entry and reconciliation in various clinical systems and tracking tools
- Provide direct TMF support to clinical trial activities conducted by Ultragenyx
- Follow up on quality findings
Technical Requirements & Skills:
- Bachelor's or Associate's degree and 0-2 years of professional clinical trial experience OR a high school diploma and a minimum of 3 years of clinical support experience with essential regulatory documents
- Demonstrated experience or knowledge with sponsor or CRO clinical research process, including collection of documents at study start-up, during study conduct and close-out
- Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable
- Previous experience working independently and efficiently after training/onboarding
- Strong computer skills (MS Office) including exposure to data/document management systems
- Must be able to work quickly, prioritize effectively, and show attention to detail
- Good communication and interpersonal skills
Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: firstname.lastname@example.org.