The Submission Readiness Manager is responsible as the Subject Matter Expert for provision of advice and training on all of Biogen's submission document word / PDF formatting, working to identify authors cross-functionally within R&D, PO&T and beyond.
Acts as the primary point of contact with the vendor(s) and manages / oversees their Submission Readiness checking / remediation work.
Partners with Submission Management to understand where the current gaps / issues are and to support any urgent remedial work needed for in-process submissions.
Ensures document deliverables for regulatory submissions from authoring community are in line with Biogen's submission standards and expectations of quality, and proactively trains / advises on how to comply with these standards and expectations.
Identifies and raises visibility of agency guidance updates relevant to document formatting / submission readiness and supports innovative process change for improved efficiency, for example automation.
The Submissions Readiness Manager is responsible for the following:
Communication with departmental submission document authors: Provision of in-person and online training & raising awareness of new submission-readiness process
Act as the company subject matter expert and support authors with formatting / templates / tools queries (via a central mailbox)
Provide oversight, training and guidance to Submission Readiness vendor(s), oversee the new process, track metrics & respond to queries
Support quality of in-process submissions, and proactively partner to resolve document-related issues in real-time to ensure submission timelines are not impacted
Understand and communicate impact of Agency guidance or other external changes relevant to document formatting and submission readiness
Ownership of document templates, with input from relevant SMEs to maintain, and oversight of relevant tools
Interact with Partner functions (e.g. Contracts Management to have standards embedded in new contracts with CROs, etc.) and track metrics on progress
4 to 6+ years pharmaceutical and regulatory experience (biotech products preferred)
2+ years regulatory operations or document formatting experience
SME Submission Readiness, Word & Acrobat
Vendor management experience beneficial
Strong communication skills in global and virtual teams
Education: Bachelor's Degree (life sciences preferable, IT/Business acceptable)
All your information will be kept confidential according to EEO guidelines.