Novavax
  • 17-May-2021 to 16-Jun-2021 (EST)
  • Medical Affairs
  • Gaithersburg, MD, USA
  • Full Time - Exempt

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

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

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

The Sr Manager/Manager of Medical Information will be responsible for providing accurate, timely, fair-balanced medical information in response to medical inquiries from internal customers and external customers (healthcare professionals and consumers). The incumbent will ensure compliance with all relevant SOPs, FDA, OIG regs and guidelines pertaining to medical information, adverse event, and product complaint handling. The Manager of Medical Information will become experts in our product/s and corresponding therapeutic areas. He/She will create response documents after conducting a literature search and choosing appropriate information for inclusion. The Manager of Medical Information will share competitive intelligence as well as current publications of interest. He/She may assist in medical, legal, and regulatory review of submissions. The Manager of Medical Information may staff congress/convention booths for medical information. Lastly, he/she will provide after-hours support for emergency medical inquiries escalated from the call center vendor.

The Manager of Medical Information reports to the Senior Director, Medical Information. This position will be onsite or remote.

Responsibilities include, but are not limited to:

  • Provide accurate, timely, fair-balanced responses to medical inquiries from health care professionals and consumers
  • Write, review, and maintain/update/retire standard and custom response letters, global core response documents, and FAQs
  • Capture demographic information and medical inquiries in the Medical Information Database, as needed
  • Appropriately evaluate cases for adverse events and/or product complaints and then forward to appropriate departments, as needed
  • Provide guidance on escalated cases from the med info vendor/contact center
  • Maintain competency on Novavax product/s and their respective therapeutic area/disease state
  • Perform literature searches using PubMed, Embase, and other medical literature searching databases
  • Synthesize competitive intelligence, as well, as share relevant current publications with internal colleagues regularly
  • Perform in-depth research, analysis and interpretation of medical data
  • Assist in the creation of metrics and performance reports to Senior Management
  • Perform routine QA/QC of med info vendor
  • Develop and deliver med info training for sales, national account managers, MSLs, and med info vendor, as needed
  • Contribute in inter-departmental projects, as needed
  • Provide on-call after hours product support for escalated inquiries from call center
  • Assist in the medical and scientific review of materials for medical, legal, and regulatory review, as needed
  • Assist with staffing booth at national conventions/meetings, as needed
  • May participate in creation of Standard Operating Procedures, as needed

Minimum requirement:

  • Five years of providing medical information in the pharma/biotech industry
  • PharmD/Pharmacist
  • Medical, legal, and regulatory review experience
  • Excellent verbal and written communication skills, as well as customer service skills
  • Personal leadership, accountability, strong interpersonal and organizational skills, and the ability to work in a cross-functional team
  • Must be results-oriented and possess timely decision-making skills
  • Proven ability to perform in-depth research, analysis and interpretation of medical data
  • Proven ability to assemble evaluated information into an accurate, comprehensive and concise response document
  • Proficiency in Microsoft Office (Word, Excel, Outlook, Powerpoint), Embase, Pubmed, and Sharepoint
  • Must have working knowledge of the applicable FDA regulations/guidances, including OIG
  • Overnight travel (up to 15%), including weekends

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

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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