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Documentation Technician 3
Ref No.: 18-14567
Location: Waltham, Massachusetts
Position Type:Contract
Experience Level: 5 Years
 Description:   The main function of the Documentation Coordinator is to serve as the process owner of the Promotional Materials Review Committee (PMRC) and a member of the Windchill team.  The Documentation Technician will serve as part of the team responsible for administering, planning, implementing, integrating and supporting the Windchill PLM (Product Lifecycle Management) solutions for the PLM core process team. Specific responsibilities will include system administration, support and technical leadership within the PLM platform, system configuration and creation of formal documentation.
Principal responsibilities and duties:
•             Change Notice Originator for the team (this includes the process of submitting Document Management Change (DMC) into Windchill)
•             Review documents that are final and ready to submit into Windchill to ensure all necessary language is included.
•             Make any necessary formatting changes to documents before they are submitted to avoid rejection.
•             Maintain tracking sheet with details of DMC status and send weekly updates to product managers.
•             Keep electronic files of all documents submitted into the Windchill system
•             Set up and lead with product manager all PMRC meetings as well as document agreed upon changes to DMC documents
•             Track the completion of all DMCs in the system, including following up with reviewers to ensure timely review of DMCs
•             Follow the established policies on submission, review and release of DMCs
•             Coordinate with regulatory and marketing teams the release of completed DMCs to the FDA
 
Skills/Qualifications:
Must be organized and detail oriented. Must be able work independently but comfortable interacting independently with various groups within the company. Must be motivated and willing to take on challenges. Takes initiative to problem solve and communicate with extended team members. Proficient in MS Office and ability to learn and use other software applications. Experience with Document Control databases such as Agile Strong communication skills. Ability to work in a fast-paced environment. Education/Experience: Bachelor's Degree or equivalent experience. Technical Writing or Document Control experience in an FDA regulated environment, preferably medical devices and/or in pharma. Experience with Design Control. Experience with revision control.