R&D Compliance Manager III

  • location: Cambridge, MA
  • type: Contract
  • salary: $60 - $67.38 per hour
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job description

R&D Compliance Manager III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

 
location: Cambridge, Massachusetts
job type: Contract
salary: $60.00 - 67.38 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Assign training in learning management systems (LMS) specifically QUMAS and SABA identified by GRA compliance training team
  • Support internal and external partner requests to manage and transfer training material (multiple LMS systems being used during integration)
  • Run LMS reports as needed to support business requests and provide GRA with overdue training data upon request or schedule (based upon need/audits prep)
  • Support GRA QMS compliance mailbox, including triage requests, sending to appropriate GRA Compliance resources
  • Support integration initiatives and workstream activities from a training and documentation administration including curricula clean up.
  • Support the Technical Writing for the GRA SOP integration work streams.
  • GRA Compliance work to support LOC monitoring (confirm local label implementations, confirm local CMC changes, confirm local ASR submissions) and update of relevant systems for tracking LOC compliance (e.g. TRAIL, Submission Calendar, etc.)
  • Support the initiation, investigation, and closure of GRA Quality Events
 
qualifications:
  • Experience with LMS maintenance and reporting functionality (SABA and QUMAS preferred)
  • Experience in partnering with internal and external stakeholders and staff to manage training data
  • Experience using SABA and/or QUMAS from an administrative perspective
  • Experience with Microsoft SharePoint (ability to create and administer preferred)
  • Ability to multi task
  • Good verbal and written communication skills
  • Experience within a regulatory/compliance life sciences organization
 
skills: MS-WORD, Learning & Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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