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If you find science, speed, and helping address serious infectious diseases exhilarating, 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.
The Associate 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. The successful candidate will be detailed oriented, self-directed, and with the ability to be flexible and manage workload to meet project timelines.
This position reports directly to the Head of Medical Writing.
Responsibilities include but are not limited to:
- 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:
- 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 crossfunctional 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).
Education, Experience, Licenses & Certifications
- Bachelor's Degree or higher, with minimum of 5 years medical writing experience as a principle medical writer or equivalent.
- Previous vaccine experience preferred.
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.