Reporting to the Senior Manager, Records Management, the Senior Associate II, Records Management provides compliance and quality assurance support to Biogen R&D departments regarding the management of R&D records throughout their lifecycle.

Additionally, the Senior Associate II works with the Senior Manager, Records Management to support R&D colleagues who 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 that R&D and its personnel consistently adhere to the highest ethical standards and comply with applicable legal and regulatory records management requirements. He or she will support the communication and education of staff on records policies and governance.

The Senior Associate II will be a part of the organization’s records management function responsible for developing and implementing the records management program for R&D, which will include the standards, tools, processes and systems necessary to ensure records management compliance. The Senior Associate II will support workstreams and projects that deliver key strategic objectives and align with and support projects involving records management.

Because the organization’s functions are themselves accountable for implementing projects and solutions for records management compliance within their functional areas, the Senior Associate II will focus on providing functional expertise for successful implementation. In addition, the Senior Associate II will share responsibility for delivering the records management vision to the organization as part of a team that interacts across R&D.

- Provide support to Senior Manager, Records Management in providing advice and expertise to all business partners on best practices in records management, serving as a Center of Excellence for R&D.

- Provide support for program and project management support for records management projects.

- Creation and delivery of training materials/resources to support records management initiatives across R&D.

Prefer at least 3 years of 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 with progressively increasing responsibilities.

Technology -- ability to assess and convey to others the implications of computerizing records management processes. For example, an understanding of validation process and 21CFR Part 11 "Electronic Records, Electronic Signatures" is an important competency for this role.

Ability to interpret records management-related regulations, guidelines and policies - understand where to find and keep up to date with new and updated regulations, guidances and policies.

Education:

Bachelor’s degree in relevant field (e.g. business, records management, information management). Advanced degree such as Master's in Library/Information Sciences desirable.

Reporting to the Senior Manager, Records Management, the Senior Associate II, Records Management provides compliance and quality assurance support to Biogen R&D departments regarding the management of R&D records throughout their lifecycle.

All your information will be kept confidential according to EEO guidelines.