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- Supports annual safety reporting (e.g., DSUR, PSUR, BLA, NDA, PMR, PADER, IND, ODD).
- Edits, reviews and approves summaries for annual reports.
- Coordinates and provides input responses to Competent Authorities or PRAC and/or CHMP safety questions, ad-hoc safety-related labeling changes, and significant safety events.
- Conducts surveys to countries which may include assessing global regulatory requirements for whether a change requires reporting, the type of reporting, or the reporting requirements for significant safety events.
- Assists with submission documents such as financial disclosure, user fees and notes to reviewers.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Bachelors degree in Science (Biology, Chemistry etc.) degree required (Health degree e.g., nursing or other health related discipline preferred)
- Basic understanding of scientific disciplines required
- Understanding of FDA regulations governing IND's, NDA's, GCP's, submission processes, submission content, and specific time requirements for various submissions desired
- Ability to organize and prioritize tasks and work independent of manager
- Abilityto think of new and better ways to accomplish tasks
- Good computer skills required
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?