25 Feb
Sr Manager, Regulatory Information Management
Massachusetts, Cambridge , 02138 Cambridge USA

Vacancy expired!

Job Description

  • Demonstrate leadership within TADI RIM seeking opportunities for new experiences and living the Biogen values. Supervisory responsibilities for Regulatory Business Systems Operations team
  • Regulatory Business Systems Operations: Defines centralized business admin function across Regulatory systems; Aids in defining RIM KPI’s
  • Sets the monitoring and enforcement of RIM data standards; establishes centralized data services within RIM capabilities (support of regulatory “events” in GRIT, BEAMS, etc.); manages centralized data services connecting to enterprise services (Clarity data entry, etc.); supports the operational reporting needs of Regulatory Data Sciences
  • Primary business partner for major Regulatory-IT capability related projects. Leads smaller projects and is the workstream lead on major programs, providing SME guidance on RIM & the related business processes. Will be owner of one or more of the RIM systems and supports the RIM Roadmap.
  • Using knowledge of Regulatory Systems, RIM and telematics, supports translation and implementation of related Global Health authority guidelines/regulations (IDMP, etc.)
  • Represent Biogen 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 or life sciences preferable)
  • 5 - 10 years of experience of experience in Pharmaceutical, Bio-Technology, or Life Sciences, with a specific focus in Regulatory of at least 5+ years and working knowledge of Biopharma development and approval process, including related HA laws and regulations
  • 5+ years experience in Regulatory Information Management (RIM) or similar capability model in GxP/Regulated Systems
  • SME-level knowledge of and experience with industry regulatory systems (e.g. Insight, Veeva vault, Lifesphere, etc.) and/or Regulatory Operations
  • Experience managing/supervising & developing people
  • Experience in implementing regulatory systems with familiarity on industry best practices and capabilities across Regulatory Processes and Systems.
  • Proven Customer and Business Relationship Management skills
  • Proven networking ability and change management experience

Additional Information

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

Vacancy expired!


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