Associate Director, Medical Writing

If you find science, speed, and helping address serious infectious diseases exhilarating

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, you have come to the right place.

Individually, we’re skilled, driven, and confident risk-takers. Collectively we’re collaborative and accomplished. We’re SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you!

Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world’s most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide.

Serve as Medical Writing Lead preparing and reviewing complex clinical documents (eg, clinical study reports [CSRs], protocols, Investigator’s Brochures [IBs], and Biologic License Application [BLA] clinical documentation).

  • Analyzing clinical data in the form of tables, figures, and listings.
  • Coordinating preparation of clinical documents for regulatory submissions.
  • Lead significant workstreams involving work across departments or 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 teams and leading medical writing initiatives within the organization.

 

Minimum Requirements

 

  • Bachelor’s Degree or higher, with minimum of 5 years medical writing experience as a principle medical writer or equivalent.
  • Ability to lead meetings and interact cross-functionally to ensure timely delivery of Medical Writing projects.
  • Experience producing high-quality clinical and regulatory submission documents
  • Excellent written and oral communication skills.
  • Ability to manage work independently or in a collaborative setting in the context of cross-funional teams.
  • Strong command of statistical concepts and techniques.
  • Strong command of FDA regulations, GCP guidelines, and industry recommendations for the conduct and reporting of clinical studies.
  • Expert in word processing (MS Word®).

 

Additional Skills/Preferences

 

  • Previous vaccine experience preferred.Excellent attention to detail and ability to find and correct errors in spelling, punctuation,
  • grammar, consistency, clarity, and accuracy.

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