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Associate – Biotech Global Regulatory – Publication (JP7368)

Thousand Oaks, California
Job Title:  Associate – Biotech Global Regulatory – Publication (JP7368)
Location: Thousand Oaks, CA. (Onsite Essential)
Employment Type:  Contract
Business Unit: GRO - PUB - UK
Duration: 12+ months (with likely extensions)
Rate: $23-26/Hour (W2)
Posting Date: 6/15/20
 
3 Key Consulting is hiring an Associate (entry) level position  for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
  • Creation and submission of regulatory dossiers according to FDA requirements, eCTD Guidance &
    Specifications and agreed upon timelines
  • Preparation of submission ready components from internal contributors according to regional regulatory guidance and internal standards
  • Contribution to submission strategy and timing
  • Contribution to the filing of ex-US regional submissions
  • Development of global training and documentation for publishing
  • Creation and maintenance of technical manuals, training documentation and SOPs
  • Participation in information system and software update projects as well as ongoing system validations
  • Interaction with vendor and supplier staff
  • Supervision of contractors in the conduct of their duties 
 
Top Must-Have Skill Sets:
  • Regulatory experience
  • Development of global training and documentation for publishing
 
Day to Day Responsibilities:
  • Creation and submission of regulatory dossiers according to FDA requirements, eCTD Guidance
    & Specifications and agreed upon timelines
  • Preparation of submission ready components from internal contributors according to regional
    regulatory guidance and internal standards
  • Contribution to submission strategy and timing
  • Contribution to the filing of ex-US regional submissions
  • Development of global training and documentation for publishing
  • Creation and maintenance of technical manuals, training documentation and SOPs
  • Participation in information system and software update projects as well as ongoing system
    validations
  • Interaction with vendor and supplier staff
  • Supervision of contractors in the conduct of their duties
     
Employee Value Proposition:
Opportunity to join a dynamic team and chance for advancement.
 
Red Flags:
Someone without bio-pharma experience
 
Interview process:
Phone / Video Skype
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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