Records Management Associate, Millennium: The Takeda Oncology Co., Cambridge, MA

Posted April 10, 2016

Position Summary: Associate, Records Management, will support the archiving and records management of Regulatory Submissions and Correspondence. The Associate will help Submission Operations in its strategic direction for Takeda for archiving activities within content management and regulatory interaction (submissions, correspondences, etc.) tracking systems.

Duties and Responsibilities:

• Support Regulatory Records Management (Regulatory Archive) business function making submission and other Regulatory documents available electronically.
• Support the centralization of all Regulatory submission documents, FDA telephone contact sheets, and any other documentation pertinent to Regulatory Affairs record retention policy and in some cases in hard copy.
• Use the document management tool to centralize submission documents electronically for Regulatory’s central repository.
• Help match off-site and Regulatory archive room documents to reduce amount of paper documents .
• Quality controls the electronic documents and hard copies to ensure accuracy.

Qualifications:

Experience:

• 2-5 years business experience working in records management/law office/office Management, working in the Biotech/pharmaceutical industry preferred
• Experience with various technology (i.e. software packages, databases, electronic records)
• Detailed oriented
• Be able to multitask
• Creative minded and being able to execute ideas
• Experience in records management (Iron Mountain experience a plus)
• Understands the concept of electronic records management, having an understanding of 21 CFR Part 11
• Proficient with EDMS (Documentum)

Other:

• Associate Degree in science or business
• BS or BA in science or business preferred
• Team player
• Excellent verbal and written communication skills
• Self starter and motivator
• Have good problem-solving skills
• Creative
• Flexible