9442 - Regulatory Affairs Associate, Senior Associate II, Records Methodology and Guidance 

03/26/2018 to 09/28/2018


Senior Associate II, Records Methodology and Guidance 

Reporting to the Director, Records Methodology & Guidance and TMF, the Senior Associate II, Records Methodology and Guidance provides compliance and quality assurance support to all Global Development departments regarding the management of Global Development records throughout their lifecycle. 

Additionally, the Senior Associate II works with the Senior Manager, Records Methodology & Guidance to support Global Development 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 that Global Development 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 Global Development, 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 Global Development. 

Provide support to Senior Manager, Records Methodology & Guidance in providing advice and expertise to all business partners on best practices in records management, serving as a Center of Excellence for Global Development. 

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 Global Development 

In collaboration with IT and appropriate business partners, maintain appropriate records management process and system solutions. These solutions will include basic records management processes and applications, such as an electronic archiving process/solution. 

Facilitate workstreams such as Authortative Source across Global Development and provide ongoing support for the Authoritative Source Map.  

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). 

Execute on the Mergers / Acquisitions / Alliances / Divestitures framework supporting information integration activities required for mergers, acquisitions, alliances and divestitures. 

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


Dawn Carey

Executive Contract Recuiter Pharmceuticals