FDA OCS Services

Job Number: 26-00288 – 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!

• This individual will work across various clinical projects across the FDA Office of Computational Sciences supporting the responsibilities.
• 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.

• Minimum of 5 years’ experience as a reviewer scientist working on drug applications of various types or pharma background with PI/study director/study investigator experience.
• Understanding of FDA CDER organization and clinical drug safety review process.
• Wide breadth of understanding of various medical specialties such as oncology, cardiology, internal medicine.
• Exposure to CDISC standards and PHUSE working groups.
• Demonstrated capacity to harness safety analysis tool technologies in the service of conducting drug safety review activities.

• Experience with clinical analytical tools such as MAED (or other Adverse Events Analysis Software), JMP/JMP Clinical, Pinnacle
  21 Data Validation Engine, and SAS.
• Experience with data standards such as CDISC Data Standards (SDTM/ADaM) and MedDRA.
• Strong project management skills.
• Experience with clinical informatics and the IT systems that support them.
• Experience leading clinical trials and shaping clinical trial design.
• Experience with conducting drug safety reviews and drug safety analyses.
• Experience working with medical reviewers.
• Experience with drafting information requests (IRs) from FDA and/or responding to them on behalf of industry.

• 401k Retirement Savings Plan administered by Merrill Lynch.
• Commuter Check Pretax Commuter Benefits.
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO.

Contact:
Carlo Flores

Carlo Flores | Linked In

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.