Vacancy caducado!
Job Description
- Regulatory Business Systems Operations: advises on 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; advisesand supports the data reporting, analysis, and interpretation for the Regulatory department
- RIM Application SME for Regulatory-IT capability related projects. Typically sits in multiple works treams, providing SME guidance on RIM & the related business processes. Can be a workstream lead for mid size programs. Will be the owner of one or more of the RIM systems, and supports the RIM Road map.
- Collaborates with functional SMEs within GSRS (e.g. Emerging Markets, Submission Sciences) and partner lines (e.g. RegCMC, IT) to understand business needs for new solutions, or modifications to existing solutions. Documents business requirements for regulatory solutions, ensuring endorsement and alignment from key stakeholders, and partners with IT to develop approach for execution and delivery
- Engagement 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)8+ 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 drug development and approval process.
5+ years experience in Regulatory Information Management (RIM), Regulatory EDMS capabilities, or operations in a similar capability model in GxP/Regulated Systems
Subject matter expertise within applicable Regulatory Agency regulations, guidelines, and specifications (e.g. FDA/EMA, ICH, eCTD, IDMP) and industry best practices pertaining to Regulatory Processes & Systems
Regulatory operations experience; submissions publishing a plus.
Familiarity with MDM & enterprise reporting capabilities a plus (e.g. Tableau, etc.) Project Management skills and competencies
Additional Information
All your information will be kept confidential according to EEO guidelines.
Vacancy caducado!