Medical Writing Manager

Novavax

Education
Benefits

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

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

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

The Manager of Medical Writing will be a key member of the Medical Writing Department responsible for reviewing (for quality), coordinating, and assisting in the preparation 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

  • Reviewing, coordinating, and assisting in the preparation of complex clinical documents (eg, clinical study reports [CSRs], protocols, Investigator’s Brochures [IBs], and Biologic License Application [BLA] clinical documentation) for completeness, consistency, correctness, and clarity. 
  • Assisting in the managing third-party vendors for medical writing deliverables. 
  • Representing medical writing on cross-functional teams and assisting in medical writing initiatives within the organization. 

Minimum requirements

  • Bachelor’s Degree or higher, with minimum of 5 years of industry experience including at least 3 years of document review experience. 
  • Ability to ensure timely delivery of key submissions. 
  • Excellent command of the English language, both oral and written, with adequate scientific understanding. 
  • Ability to manage work independently or in a collaborative setting in the context of crossfunctional teams. 
  • Experience 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.  
  • Excellent attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy. 

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.

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.

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Confirmed 16 hours ago. Posted 22 days ago.

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