Commercial Documentation Manager

Role Summary

The Commercial Documentation Manager will coordinate, distribute, track and report on the status of documents throughout the review and approval cycle. This role will also ensure that the final approved versions are stored electronically in the appropriate locations. This role will communicate directly with internal and external project managers regarding status and distributing documents.

Responsibilities

• Manage email mailbox for all incoming/outgoing documentation from external sources and vendors.
• Upload documents into the review and tracking software with the appropriate reviewers, due dates and supporting information.
• Manage documents through the review cycle by collecting internal comments, returning comments to the vendor, ensuring comments are addressed, supporting document approval and storing the current effective version appropriately.
• Track and report progress on documents in the review cycle.
• Support Veeva change controls and corresponding commercial documents.
• Data entry supporting commercial stability programs.
• May include data entry supporting manufacturing of commercial batches.
• Support critical business meetings by managing presentation versions, meeting minutes, and action items.
• Work may be done remotely but occasional travel to team planning meetings may be required.
• Other duties as assigned.

Qualifications

• Bachelor‚Äôs degree in a related field required, preferably in a technical or scientific area of study with a minimum of 5 years working in a scientific environment with a preference for Chemistry, or an equivalent combination of education and experience.
• Experience working in a GMP environment with experience using and/or reviewing GMP documentation is a plus
• Demonstrated ability to work both independently and collaboratively in a remote environment
• Self-motivated worker able to establish and deliver timelines, communicate effectively across teams, and act as a subject-matter expert for the commercial documentation requirements
• Demonstrated ability to effectively manage priorities and diligently follow through to completion of work in timely manner.
• Experience interacting with various vendors to initiate and finish documentation updates.
• Expertise in Microsoft Office software, Adobe and related document management software to generate, modify and track documents including conversion to and from PDF and other formats. Experience in quality and review software, such as Veeva and PleaseReview is preferred.
• Good written and verbal communication and presentation skills.

Education

• Bachelor‚Äôs degree in a related field (required)

Skills

• Document management software (e.g., Veeva, PleaseReview)
• Microsoft Office suite
• Adobe software
• Quality and regulatory documentation review
• Effective written and verbal communication

Additional Requirements

• Occasional travel to team planning meetings may be required