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Assistant Fda Cder Jobs (NOW HIRING)

Exegenesis Bio Inc

Head of Regulatory Affairs

Ambler, PA · Remote

$153K - $202K/yr

... FDA and other regulatory issues to company personnel and assist as a liaison between the company ... with CDER and CBER * Extensive knowledge of clinical development, FDA and international global ...

Exegenesis Bio Inc

Head of Regulatory Affairs

Ambler, PA · Remote

$153K - $202K/yr

... FDA and other regulatory issues to company personnel and assist as a liaison between the company ... with CDER and CBER * Extensive knowledge of clinical development, FDA and international global ...

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Computer Operator II

Ivyhill Technologies LLC

Rockville, MD • On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 23 days ago

Job description

Ivyhill has an immediate need for a Computer Operator II that will support our their FDA CDER DCC project in Rockville, MD. The Computer Operator II (CO2) will process scheduled routines that present few difficult operating problems (e.g., infrequent or easily resolved error conditions). In response to computer output instructions or error conditions, the CO2 applies standard operating or corrective procedures, refers problems that do not respond to pre-planned procedures, and may serve as an assistant operator, working under general supervision.
Key Responsibilities:
  • Receive, process, and load physical electronic submissions to an electronic repository
  • Handle electronic file maintenance and maintain file storage
  • Load emails, notifications, and files to a tracking IT system
  • Perform a quality review of processed work
  • Update/verify entries in the electronic repository
  • Prepare and send email notifications to project review team
  • Process electronic submissions, including coding and data entry into DARRTS
  • Research complex problems and provide detailed resolutions
  • Update tracking databases to ensure completeness and timeliness of tasks performed
  • Respond to client requests
  • Process notifications and conduct data cleanup tasks
  • Develop and maintain documentation, including SOPs and technical documents

Requirements
The qualified candidate will have the following:
  • U.S. Citizenship.
  • Minimum of a high school diploma or equivalent.
  • Excellent organizational and interpersonal skills
  • Excellent communication skills
  • Excellent, proven computer skills required to perform the job requirements
  • Willingness to learn and participate in a team effort
  • Ability to sit, stand, bend, stretch, lean and lift 30 pounds as required when handling boxes of records.

(Candidates who reside in a qualified HUBZone area are a plus. Please confirm qualified HUBZone eligibility by accessing the HUBZone Map: (https://maps.certify.sba.gov)).
Benefits
Ivyhill has a comprehensive benefits package that includes Group Life Insurance and AD&D, healthcare, dental care, vision coverage, Supplemental Life Insurance and a 401(k) Plan.

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