Director/Senior Director, Medical Writing
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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 Director/Senior 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 detail 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 (e.g., 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.
- Bachelor’s Degree or higher, with minimum of 5 years medical writing experience as a principle medical writer or equivalent (more experience required for more senior positions).
- Ability to lead meetings and interact cross-functionally to ensure timely delivery of Medical Writing projects.
- Lead author on multiple CSRs and/or protocols.
- 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‑functional teams.
- Able to manage multiple priorities and adapt quickly to new situations and new project demands.
- 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®.
- 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 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Gaithersburg, Maryland, USA
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