Submission Readiness Operations - Manager

Biogen Idec Cambridge , MA 02138

Posted 2 months ago

Company Description

Job Description

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

Qualifications

  • 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)

Additional Information

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


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