Ionis Pharmaceuticals
Senior Trial Master File (TMF) Manager
This job is now closed
Job Description
- Req#: IONIS003278
Employer Industry: Biopharmaceuticals
Why consider this job opportunity:
- Salary up to $119,188
- Opportunity for career advancement and growth within the organization
- Supportive and collaborative work environment
- Chance to work with cutting-edge RNA technology for human therapeutics
- Comprehensive benefits package offered
- Remote work flexibility available
What to Expect (Job Responsibilities):
- Ensure inspection readiness of Ionis Trial Master Files (TMF)
- Monitor adherence to ICH/GCP Guidelines and regulatory requirements
- Collaborate with cross-functional, global clinical research studies
- Perform risk-based quality reviews of TMF content
- Assist in overall change management and build collaborative relationships with teams and vendors
What is Required (Qualifications):
- Minimum of Bachelor’s degree in a scientific or related discipline
- 3-5 years of TMF experience required
- 2 years of experience with Veeva Vault eTMF system
- Knowledge of Core, Country, and Site level essential documents
- Strong communication and interpersonal skills
How to Stand Out (Preferred Qualifications):
- Experience in study start-up, maintenance, and closeout
- Proficiency with Window Office tools
- Knowledge of ALCOA+ standards, Good Clinical Practice, and International Council for Harmonization guidelines
#Biopharmaceuticals #ClinicalResearch #TMFManagement #CareerOpportunity #RemoteWork
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We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.About the company
Ionis Pharmaceuticals is a biotechnology company based in Carlsbad, California that specializes in discovering and developing RNA-targeted therapeutics.
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