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Associate Director, Safety Medical Writing, Global Vaccine Safety

Novavax

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Gaithersburg, MD
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Job Description

As posted by the hiring company

Job Overview:

**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.**

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 Associate Director, Safety Medical Writing, Global Vaccine Safety will be responsible for Safety Medical Writing throughout all stages of clinical and post authorization product lifecycles. 

Responsibilities include but are not limited to:

  • Support Global Vaccine Safety (GVS) Safety with regards to safety medical writing activities.
  • Author a wide range of pharmacovigilance documents including but not limited to Periodic Safety Reports, Signal Evaluation Reports, Benefit-Risk Documents, Clinical Development Safety Documents, Patient Safety Narratives and Health Hazard Reports.
  • Author responses to Health Authorities queries.
  • Effectively and clearly communicate technical, medical, and scientific information in critical submission and internal PV documents in order to deliver high quality reports within the specified timelines.
  • Review deliverables for data accuracy, consistency, and ensuring alignment with processes, templates, and regulations.
  • Participate in meetings related to key GVS activities.
  • Collaborate cross functionally for continuous improvement of standards and best practices for medical writing.

Minimum Requirements:

  • Graduate degree or equivalent job experience with comprehensive pharmacovigilance knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
  • Excellent written and spoken English (including medical terminology) with a familiarity with AMA style guide.
  • A minimum 10 years' experience in drug/patient safety) required.
  • Demonstrated experience in Periodic Safety Reports of interpretation & presentation of aggregate safety data.
  • Strong knowledge of regulations and guidelines (FDA, EMA, ICH, EU GVP, etc.).
  • Experience in signal management, benefit-risk assessment, literature surveillance.
  • Proven experience in ability to consistently produce documents of high quality and express complex data in a concise and easy-to-read way.
  • Comprehensive experience in working in cross-functional, global teams, across different regions and time zones.
  • A flexible attitude with respect to work assignments and new learning; readily adapts to changes.

Preferred Qualifications:

  • Experience in vaccine pre- and post-authorization development programs
  • Strong attention to detail and persistence in following tasks through to completion
  • Good organizational and prioritization skills
  • Good interpersonal skills
  • Ability to work independently
  • Flexibility and ability to adapt and learn quickly
  • Ability to work under pressure and to tight deadlines
  • Excellent communication and presentation skills in English (both written and spoken)

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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