-
ID
#13322552 -
Job type
Full-time -
Salary
TBD -
Source
Biogen -
Date
2021-04-14 -
Deadline
2021-06-13
Sr. Associate, Regulatory Information Management
Massachusetts, Cambridge, 02138 Cambridge USAVacancy expired!
Job Description
- Regulatory Business Systems Operations: supports centralized function across Regulatory systems which leads the monitoring and assurance of data standards; centralized data services within RIM capabilities; supports centralized data services to enterprise services to support resource management and allocation; advices and supports the data reporting, analysis, and interpretation for the Regulatory department
- RIM Application SME for Regulatory-IT capability related projects. Typically sits in multiple workstreams, providing SME guidance on RIM & the related business processes. Will be the owner of one or more of the RIM systems, and supports the RIM Roadmap
- Using knowledge of Regulatory Systems, RIM and telematics, supports implementation of related Global Health authority guidelines/regulations (IDMP, etc.) into RIM. Can engage on industry associations and provide input to intelligence/policy initiatives in alignment with internal and external stakeholders, ensuring a focus on Biogen’s interests.
Qualifications
- Bachelor’s Degree (Information Systems of life sciences preferable)
3+ years of experience of experience in Pharmaceutical, Bio-Technology, or Life Sciences, with a specific focus in Regulatory of at least 2+ years and working knowledge of Biopharma development and approval process, including related HA laws and regulations preferred
2+ years experience in Regulatory Information Management (RIM), Regulatory EDMS capabilities, or operations in a similar capability model in GxP/Regulated Systems preferred
Regulatory operations experience; submissions publishing a plus
Familiarity with MDM a plus
Familiarity with enterprise reporting capabilities a plus (e.g. Tableau, etc.)
Experience with regulatory systems and processes with familiarity on industry best practices and capabilities across Regulatory Processes and Systems
Customer and Business Relationship Management skills
Additional Information
All your information will be kept confidential according to EEO guidelines.
Vacancy expired!