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Regulatory Affairs CMC Senior Associate (JP7215)

Boston, MA · Biotech/Pharmaceutical
Job Title:  Regulatory Affairs CMC Senior Associate (JP7215)
Location: Boston, MA or Thousand Oaks, Ca. Remote work during Covid-19 restrictions.
Employment Type:  Contract
Business Unit:  CMC Devices and Biosimilars
Duration: Initial 8 months with likely extensions
Job posting date: 4/23/20
 
3 Key Consulting is hiring a Regulatory Affairs Senior Associate for a consulting engagement with our client, a leading global biopharmaceutical company.
 
Ideal candidate: Previous experience with our client in the biotech industry, CMC, System/Programming knowledge

Job Description:
Assist in the development of module 3 templates that will enable population by automation tools and enable structured content management. Knowledge of the Common Technical Document (CTD), such as Module 3 for regulatory documents such as CMC related sections. Must have some knowledge of CMC and structured content. Be prepared to work within data systems and processes related to regulatory submissions. Working with cross collaborative teams and CMC authoring. IT experience/programming experience in context of CMC/Module 3 a plus
 
Why is the Position Open?
Supplement additional workload.
 
Top Must-Have Skill Sets:
  • 1-2 years of regulatory experience
  • Common Technical Document (CTD) such as module 3 knowledge
  • Data systems experience and processes for regulatory submissions
     
Day to Day Responsibilities:
Will work within databases with a team on updating CMC templates to enable automation.
  
Employee Value Proposition:
Ability to work cross functionally on a top priority team
 
Red Flags: No RA experience 
 
Interview process:
Phone screening followed by 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 look at the other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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