Manager, R&D Records Management

Company Description

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. 

Job Description

About This Role

Reporting to the Associate Director, R&D Records Management, the Manager provides quality and compliance support across the organization for management of records throughout their lifecycle. In addition, the Manager works closely with the Information Governance team providing input on records retention schedule changes, controlled document updates, system assessments, and Enterprise Archive processes/ingestions. This role is also responsible for completing legal requests, archiving activities, and records transfers related to asset acquisitions, mergers, and divestitures.

**The role is hybrid-based which requires periodic onsite support on our Cambridge Massachusetts campus.**

What You’ll Do

• Provide input into training materials and resources designed to communicate records management policies and best practices to all business partners. 

• Assist in revising R&D Records Management controlled documents as necessary due to Company needs and/or changes with regulations or policies. 

• Team member on workstreams related to records transfers to ensure functions receive and have access to relevant business records.  

• Maintain knowledge of the Global Records Retention Schedule and be able to effectively communicate to various departments regarding retention and disposition of records. 

• Help locate and produce records as needed for legal proceedings and audit/inspection support. 

• Complete onsite and offsite records reviews at various locations including preparing/shipping records for offsite archival and determining disposition of records no longer required for legal or business purposes. 

Qualifications

Who You Are

You like variety in the work environment with an interest in being onsite performing certain tasks. You understand the importance of records management and enjoy collaborating cross functionally to help teams achieve key program deliverables. You keep patients at the forefront of your goals and accomplishments while understanding the critical work required to develop life changing therapies. You thrive in a highly regulated environment and use strong technological skills and tools to efficiently complete a variety of activities. 

Required Skills

• Bachelor’s degree in relevant field (e.g. Records/Information Management with preferred specialization in an area related to Pharmaceutical, Biotechnology, Health Sciences, or Biology). 

• At least 5 years of biotech/pharmaceutical experience, specifically in records management within a global corporation.

• Knowledge of records generated and maintained by an R&D organization from early research to product development and marketing. 

• Able to interpret and remain up to date on records management-related regulations, guidelines, policies.  

• Strong analytical skills with knowledge of various technology tools including document management systems, enterprise content management systems, Microsoft 365 platform, and cloud-based storage solutions. 

• Ability to establish strong and collaborative relationships with key stakeholders. 

• Proficient in presenting to a broad audience, self-motivated, and able to work independently. 

Additional Information

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