25 Feb
Sr Manager, Regulatory Information Management
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!