Manager, Records Methodology & Guidance, Integrated Resources Inc., Cambridge, MA

Posted May 14, 2015

Job Summary

Reporting to the Associate Director, Records Methodology & Guidance, the Manager, Records Methodology and Guidance provides compliance and quality assurance support to all Development Sciences departments regarding the management of Development Sciences records throughout their life-cycle.

Requirements

• Develops and implements practices, education, tools, and communications to support the functional area departments in assessment and remediation of their respective sets of Development Sciences records.
• Develops and executes education, awareness and learning to support Knowledge, Records and Information Strategies initiatives across Development Sciences.
• Acts as a point of coordination for records specialists within the respective Development Sciences functional areas.
• Ensures that no gaps exist in the overall system of Development Sciences records, and that functional area departments interface successfully.
• Identifies and assesses risks associated with records management.
• Recommends strategies and processes that will improve quality and mitigate risks.
• Measures, monitors and reports on compliance with records management policies and procedures.
• The Manager is also responsible for developing and executing strategies for education, awareness and learning across Development Sciences for all Knowledge, Records and Information Strategies initiatives.
• Additionally, the Manager works with Development Sciences colleagues to develop, execute and measure records-related programs and internal controls to ensure that operations are conducted in compliance with applicable records management standards, and to ensure Development Sciences and its employees consistently adhere to the highest ethical standards and comply with all legal and regulatory records management requirements.
• He or she is responsible for communicating and educating staff on knowledge, records and information policies and governance.
• This individual interfaces with all levels of staff as well as with external consultants as necessary to execute the departmental strategy according to goals, plans and objectives.

Other job duties include:

• Determines and communicates authoritative sources and systems of record (including change control process) for R&D records.
• Determines with R&D Compliance the focus areas for the audit plan as it relates to records management issues and challenges.
• Maintains awareness of trends, technologies, practices and issues in records management. These include compliance, archiving, storage, disposition practices, litigation, emerging technologies and standards (e.g. 21 CFR Part 11).
• Develops and implements new processes, methods and systems to manage records and data life-cycle, regulatory requests, subpoenas, and reporting routines.
• Prepares and delivers effective presentations for external and internal audiences.
• Responsible for Records Methodology & Guidance representation on project teams as assigned.

Qualifications and Experiences:

• Bachelor’s Degree in relevant field, e.g. business, records management, information management, with progressively increasing responsibilities.
• Biotech/pharmaceutical experience, specifically in the areas of interpreting regulations, guidelines and policies to create a meaningful monitoring and compliance framework in records & information management.

Please send your updated resumes at [email protected].