BioCryst Pharmaceuticals

Commercial Documentation Manager (Contract)

New

PayCompetitive
LocationRemote
Employment typeFull-Time

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  • Job Description

      Req#: COMME002131

      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.

      ESSENTIAL DUTIES & RESPONSIBILITIES:

      • Manage Outlook mailbox for all incoming/outgoing documentation from external sources and vendors.
      • Upload documents into the review and tracking software and add the appropriate reviewers, due dates and supporting information.
      • Manage documents through the review cycle, collecting and confirming comments and returning them to the author, ensuring comments are addressed, and storing the updated current version appropriately.
      • Track and report progress on documents in the review cycle.
      • Work may be done remotely but occasional travel to team planning meetings may be required.
      • May include data entry of materials used in batches, and data entry from batch records.
      • Support critical business meetings by managing presentation versions, and or meeting minutes and action items.
      • Support State Licensing activities and renewals
      • Support corporate and global insurance activities for policy updates, renewals, and certificates
      • Manage documentation in Veeva as needed in accordance with change control procedures.
      • 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 3 years experience working in scientific environment with a preference for Chemistry, or an equivalent combination of education and experience.
      • Experience in 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 setting priorities and diligently following through to completion of work in timely manner.
      • Ability to work independently and remotely after adequate training.
      • Self-motivated worker able to meet timelines provided by supervisor.
      • Ability to distinguish priorities at work.
      • Good written and verbal communication and presentation skills.
      • Basic computer knowledge needed. Experience with PleaseReview, Adobe, and Veeva is a plus..

      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.

      Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

      The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

  • About the company

      BioCryst Pharmaceuticals, Inc. is an American pharmaceutical company headquartered in Durham, North Carolina.