Job Description

Electronic Document Specialist
Job Number: 21-06706
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for an Electronic Document Specialist for our client in Lawrenceville, NJ
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Responsibilities:
  • Support Global Submissions Management in the coordination, preparation, and submission of product life cycle management activities. Responsibilities would include but not limited to:
    • Creation of Submission Content Plan
    • Ensuring documents meet submission standards
    • Downloading submission documents in preparation of vendor publishing
    • Verification of regulatory dossier submissions to meet health authority publishing standards
    • Adherence to required submission timelines, health authority publishing specifications, and internal working practices
  • Responsible for submission archiving for specific submission types within specified time frames in appropriate systems
  • Responsible for data entry into Regulatory Systems
  • Other responsibilities related to the above within Client as assigned
  • Generate reports to support metrics and quality
 
Qualifications:
  • 2 yrs. pharmaceutical industry regulatory experience
  • Experience with drug development submissions in eCTD
  • Experience with drug development submissions in eCTD
  • Proficiency with MS-Office Suite and Adobe Acrobat applications including ISI toolbox
  • Knowledge of health authority procedures/guidance's regarding electronic submissions
  • Ability to balance multiple tasks to meet priorities and timelines
  • Ability to work independently
  • Strong attention to detail and organizational skills
  • Flexible team player
  • Strong Communication Skills both written and verbal
 
Preferred Qualifications:
  • Submission experience
  • BA/BS Degree
 
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:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status

Application Instructions

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