FDA FY2025 OCS Clinical and Nonclinical Services Support
Job Number: 25-05489
Job Number: 25-05489
ECLARO is looking for an FDA FY2025 OCS Clinical and Nonclinical Services Support for our client in Remote, MD.
ECLARO’s client is a major technology firm with a prominent presence in large and fast-growing markets, providing products and services that enable businesses and economies to thrive. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Responsibilities:
- This individual will work across various clinical projects across the FDA Office of Computational Sciences supporting the responsibilities below:
- Participating as a subject matter expert for any clinical safety studies, respectively, which are submitted to the FDA in support of drug applications.
- Reviewing clinical data for regulatory compliance to ensure human subject safety and data integrity and communicating findings with a multi-disciplinary review team.
- Completing special projects that involve specific research areas and objectives to include the design, characterization, performance, and bioequivalence of complex drug products; development of advanced manufacturing approaches for drug substances and drug products; development of science-based drug quality standards; and the development of analytical and in-vitro methods to support product quality surveillance and investigate product quality failures.
- Serving as a CDER resource by participating in work groups or subcommittees.
- Publishing scientific articles within the scientist's area of expertise and maintaining contact with the "state of science” to identify and integrate the most advanced research theories and / or practices into the Center's drug regulatory programs.
Qualifications:
- Minimum of 5 years’ experience as a Reviewer Scientist working on drug applications of various types.
- Strong project management skills.
- Experience with clinical informatics and the IT systems that support them.
- Experience with clinical analytical tools such as MAED (or other Adverse Events Analysis Software), JMP / JMP Clinical, Pinnacle21 Data Validation Engine.
- Experience with data standards such as CDISC Data Standards (SDTM / ADaM) and MedDRA.
- Experience leading clinical trials and shaping clinical trial design.
- Experience at FDA or in the pharma industry extending beyond primary clinical review.
- Experience with conducting safety reviews and clinical data analytics.
- Experience with creating safety analysis to evaluate drug safety and efficacy.
- Experience working with medical reviewers.
- Experience with drafting information requests (IRs) from FDA and / or responding to them on behalf of industry.
- Expertise in identifying the type of analysis that may be limited by the data provided.
- Expertise in identifying areas of weakness in clinical submissions based on study design and provided data.
If hired, you will enjoy the following ECLARO Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
If interested, you may contact:
Carlo Flores
Carlo.Flores@eclaro.com
646-695-2934
Carlo Flores | LinkedIn
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.
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