Job Description

Quality Assurance - Clinical
Job Number: 19-04826
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Assurance - Clinical for our client in Cambridge, MA.
 
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • Global Clinical Submissions Quality Lead to support Business Development Due Diligence activities: quality lead will review external clinical data and ensure that clinical data included on due diligence packages are complete and accurate and meet global regulatory requirements and internal quality standards, procedures and business objectives.
  • Expertise in clinical development and regulatory knowledge on requirements of drugs entering the market is key.
  • The Quality Lead will ensure that clinical data included in the due diligence packages are complete and accurate and meet global regulatory requirements and internal quality standards, procedures and business objectives.
  • Global Clinical Submissions Quality Lead will work predominantly with the Business Development Due Dilligence team and GCSQ team to achieve quality goals.
 
Required Qualifications:
  • Experience in clinical development programs and global drug submissions, e.g., New Drug Application (NDA) or Biologic Licensing Application (BLA) and supplemental applications.
  • Experience in one or more of the following: clinical development (Phases 1-3), statistics, project management, regulatory, and/or Quality.
  • Experience in pharmaceutical drug development (Proof of Concept through Phase 3) or consumer healthcare products.
  • Experience with New Chemical Entity (NCE) and New Biologic Entity (NBE) products or Consumer Healthcare/OTC products.
  • Experience supporting products in the marketplace (e.g., Advisory Committee meetings, Post-Marketing Commitments, Product Labeling).
  • Outstanding written and oral communication skills and demonstrated ability to communicate well across business lines.
  • Behavioral Competencies:
    • Acts Decisively:
      • Makes timely and effective decisions by applying business acumen and seeks help quickly for prompt resolution of challenges
      • Acts with urgency and removes barriers that hinder productivity
    • Seizes Accountability:
      • Takes personal accountability for outcomes
    • Insight, Influence, and Inclusion:
      • Understands others’ unspoken, as well as explicit, concerns
      • Adapts own behavior and approach to be more effective, inclusive, and to have positive impact on others
 
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:
Maria Castañeda
maria.castaneda@eclaro.com
6463571235
Maria Castañeda | 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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