Commercial Documentation Manager

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we've been guided by our passion for not settling for "ordinary" in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow uson LinkedIn and Instagram.

JOB 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. #LI-REMOTE

ESSENTIAL DUTIES & 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.

EXPERIENCE & QUALIFICATIONS:

• Bachelor's degree in a related field required, preferably in a technical or scientific area of study with a minimum of working in 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.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.