Senior Associate II, Records Management, Biogen, Cambridge, MA
Posted July 19, 2017
Reporting to the Senior Manager, Records Methodology & Guidance, the Senior Associate II, Records Methodology and Guidance provides compliance and quality assurance support to all Biogen 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
Qualifications:
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.
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.
Apply here.