Research Outcomes Technician
Primary Responsibilities Include:
- Serves as Study Director on toxicology and related studies and oversees all technical and scientific study conduct and deliverables through study completion.
- Ensures all applicable GLP standards/ regulatory (FDA 21 CFR Part 58) are followed.
- Assures adequate test materials and test systems are available.
- Provides nonclinical expertise to a cross-functional study team.
- Works with internal functional areas to ensure all studies are performed in a high quality, timely and scientific manner.
- Designs protocols and ensures that the protocol and amendments are approved before work is executed.
- Disseminates notifications of study, protocol, and amendments/deviations to study personnel and QAU
- Authors, updates, and/or reviews area-specific SOP's and Protocols, ensuring that documents reflect current processes
- Ensures accurate documentation of study results and representation of study results
- Ensures archival of data in a timely manner
- Participates in continual improvement initiatives
Desired Education and Skills:
- Master’s degree in related field with 5+ years of experience or PhD with 3-5 years of experience; or an equivalent combination of education and or experience in a related field
- Must have at least 2 years of experience working in a GLP environment as a study director.
- Excellent writing and communication skills
- Experience in the preparation and review of regulatory documents including authoring nonclinical modules for regulatory documents
- Highly organized and able to work with great precision and attention to detail.
- Experience with statistical and computer productivity software.
- Proven ability to manage multiple projects/tasks at one time
- Experience creating and presenting scientific presentations
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.