Associate Director/Director, Medical Writing

Novavax Inc. Gaithersburg , MD 20877

Posted 2 months ago

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc.(Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavaxis currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.Novavaxis a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

The Associate Director/Director of Medical Writing will be a key member of the Medical Writing Department responsible for the preparation, coordination, and review of clinical/regulatory documents in support of our clinical portfolio of innovative vaccines.

This position reports directly to the Head of Medical Writing.

Responsibilities include but are not limited to:

  • Preparing and reviewing complex clinical documents (eg, clinical study reports [CSRs], protocols, Investigator's Brochures [IBs], and Biologic License Application [BLA] clinical documentation).

  • Coordinating preparation of clinical documents for regulatory submissions.

  • Managing third-party vendors for medical writing deliverables.

  • Supporting clinical publications (manuscripts, abstracts, and poster presentations) and publication strategies.

  • Representing medical writing on cross-functional teamsand leading medical writing initiatives within the organization.

Minimum requirements:

  • Bachelor's Degree or higher, with minimum of five years medical writing experience.

  • Ability to lead meetings and interactions to ensure timely delivery of key submissions.

  • Lead author on multiple CSRs and/or protocols.

  • Excellent command of the English language, both oral and written, with strong scientific understanding.

  • Ability to manage work independently or in a collaborative setting in the context of crossfunctional teams.

  • Able to manage multiple priorities and adapt quickly to new situations and new project demands.

  • Experience with oversight of outsourcing.

  • Strong command of statistical concepts and techniques, and immunological detection methods.

  • Escalate conflict appropriately.

  • Strong command of FDA regulations, GCP guidelines, and industry recommendations for the conduct and reporting of clinical studies.

  • Expert in word processing (MS Word) and excellent working knowledge of software programs in Windows environment such as PowerPoint, Endnote and Adobe Acrobat.

Additional Skills/Preferences:

  • Previous vaccine experience preferred.

  • Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.

  • Experience in ClinicalTrials.gov and EudraCT protocol registration/results posting.

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

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Associate Director/Director, Medical Writing

Novavax Inc.