15 May
Sr. Associate, Regulatory Information Management
Massachusetts, Cambridge , 02138 Cambridge USA

Vacancy 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!


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