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Technical Report Writer

Vaxart, Inc.

Technical Report Writer

National
Full Time
Paid
  • Responsibilities

    ABOUT US:

    Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.

    Vaxart has demonstrated that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication.

    Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.

    We are looking for a Technical Report Writer to join our growing team! This role can be based in our South San Francisco office or remote for the right candidate. 

    SUMMARY:

    The Technical Report Writer leads the generation and creation of Scientific reports derived from process, analytical, and formulation development studies. The Technical Writer helps develop technical reporting systems, writes, routes for review, and approval. The Technical Writer is expected to be the champion of the technical writing function for Vaxart Development.

    RESPONSIBILITIES:

    • Organize data, support and/or write scientific reports using standard Vaxart templates to document development studies and support world-wide regulatory filings (US, EU, and ROW) through BLA.
    • Write and edit reports prepared in conjunction with laboratory or established personnel providing the data.
    • Ensures reports based on development data justify the purpose of each set of scientific studies using standards for clarity, conciseness, style, and terminology.
    • Works with Development and Quality department staff to create a system for storage and maintenance of drafts and approved reports so that reports and their data are readily accessible for regulatory and scientific use, including the review and approval process.
    • Confer with scientists and/or associates to determine specific subject material and key messages for each report and in conjunction with scientific SME's, select tables, charts, and other data to be included in each report.
    • Review and edit reports based on recommended revisions, changes in scope, format, and content.

    REQUIREMENTS:

    • BS, MS or Ph.D. Degree in Biological Sciences or Engineering.
    • 10+ years in the pharmaceutical/biotech industry with demonstrated experience writing scientific reports for regulatory submissions (IND's, BLA's, etc.). 
    • Experience in publication in scientific journals, writing SOP's and batch records is highly beneficial.
    • A depth of knowledge of process, analytical and/or formulation development is highly beneficial.
    • Knowledge of scientific writing standards and general familiarity with the AMA Manual of Style.
    • Knowledge of standards for electronic regulatory submissions is beneficial.
    • Must be energetic, proactive and take initiative to get the job done.
    • Exceptional verbal and writing skills.
    • Highly collaborative with scientific personnel.

    VACCINATION REQUIREMENT:

    Vaxart has implemented a mandatory COVID-19 vaccination policy which requires our employees to be fully vaccinated against COVID as a condition of employment. Vaxart will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. Vaxart prioritizes sound science and available facts to best ensure the ongoing safety of our employees and the community.

    Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, bonus program, stock options, 401K with employer matching, tuition assistance, and work-life balance.

    Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, and layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by federal, state or local law, ordinance or regulation.