Regulatory Compliance Manager

Highly Competitive Salary
  1. Permanent
  2. Operations, Local Affiliate
  3. United States
Cambridge, USA
Posting date: 12 May 2020
RA.NR.29516

Proclinical is currently recruiting for a Regulatory Compliance Manager with a pharmaceutical company located in Cambridge, MA.

Job 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
  • Work with GRA Compliance staff to address customers' needs upon request, supporting continuing operations of the LMS systems to serve needs of the GRA organization
  • Support integration initiatives and workstream activities from a training and documentation administration including curricula clean up
  • Provide administrative support and accountability for the LMS including reporting, learner inquiries/education on the LMS
  • 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
  • Support GRA Compliance activities

Skills and Requirements:

  • 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 multitask
  • Good verbal and written communication skills
  • Experience within a regulatory/compliance life sciences organization

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Nikki Ranieri at 215-531-5288 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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