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18 days old

R&D Compliance Manager

Kelly Services
Cambridge, MA 02238
Kelly Services is seeking a R&D Compliance Manager III With our client in Cambridge, Massachusetts.


**Type:** Contract W2There is no per diem with this position. There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs. NO C2C, at this time we are not in the position to offer any type of sponsorships or VISA transfers for this position.


+ Duration: 05/24/2021 to 11/23/2021


2 positions - 1 for 6 months, and 1 for 9 months


Location : Cambridge, Massachusetts


Shift : *Total time commitment estimated to be between 40-46 hours per week (based upon changing business needs).


+ 5 -7 years experience

+ Support integration of QMS systems

+ Top three technical skills: systems management (LMS, QDMS), curricula development, excellent communication

+ Team is responsible for deviation, document management, learning management systems

+ Customer-facing

+ Being able to speak with employees at all levels of org

+ Knowledge of instructional design, curricula design

+ Regulatory, GxP nice to have


Soft skills: problem-solving, communication, independent, collaboration, creative/innovative, navigate ambiguity, meeting management


+ R&D experience is a plus

+ High-level Excel a plus

+ No formal date of return to the office, can be 100% remote for now but must work core EST business hours


Responsibilities:


+ Support the integration of Takeda LMS activities, including the ongoing C3 (Compliance Curricula Cleanup) project. Working across GRA key stakeholder groups to identify, manage and update curricula to a targeted role based application, and replicate across both LMS systems

+ Partner with R&D Quality, GRA Compliance to prepare LMS and eDMS systems for integration during FY2021

+ 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 system preparation, and C3 project.

+ Support the initiation, investigation, and closure of GRA Quality Events associated with training systems administration.


Skill/Experience:


+ 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)

+ Experience within eDMS systems (electronic document management system) such as Veeva Vault Quality Docs and QUMAS

+ Ability to multi task

+ Good verbal and written communication skills

+ Experience within a regulatory/compliance life sciences organization


**Why Kelly** **** **?**


By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-04-30 Expires: 2021-05-31

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R&D Compliance Manager

Kelly Services
Cambridge, MA 02238

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