Regulatory Review Assistant

GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com.

Summary

The position will serve an integral role supporting the Associate Lab Director. provides support to the CLIA Laboratory Director on day-to-day basis on reviewing validations, SOPs and other documents, manages proficiency testing program, license changes/renewals, keeping up to date on regulatory changes and providing updates to CLIA LD as needed and working closely with Quality Systems team on audits/inspections.

Job Responsibilities

• Assist ALD in preparing validation documents for review e.g., formatting Microsoft Word, Excel documents
• Assist in preparing forms/documents for license renewals
• Learn NYS test submissions process to support Lab Director team in these efforts
• Learn and understand CAP/CLIA/NYS checklists and standards to support Lab Director team
• Learn FDA LDT regulations to support Lab Director team
• Assist in collection of proficiency testing attestations from the different groups
• Work cross-functionally among teams to assist ALD in day-to-day activities
• Maintain and supplement organization of regulatory records.
• Experience in Next Generation Sequencing and other molecular techniques is required
• Experience with Microsoft Office applications is a must
• Performs other related duties as assigned

Education, Experience, and Skills

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• BA or BS degree
• Excellent oral and written communication skills
• Excellent organizational skills and ability to multitask
• Computer skills at office professional level required
• Some familiarity required with: NYS Clinical Lab Evaluation Program, and/or CAP regulations on clinical test validation; and/or genetic testing methods

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to talk or hear.  The employee is frequently required to sit.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. 

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

#LI-REMOTE