Remote Senior Medical Writer
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Remote Senior Medical Writer

Glen Allen, VA

At GENETWORx Laboratory, we improve the health and wellness of lives around the world through dedicated research, experienced scientists, 21-st century technology, and in-depth diagnostics. Healthcare is personal and as such, the future needs to be, too. By intersecting genetic testing with personalized medicine and pharmacogenomics, we’re positioning our patients and empowering physicians with more precise, individualized, effective results.
As a leader in precision COVID-19 testing, GENETWORx provides unparalleled support, results, and clarity during these uncertain times. GENETWORx has armed healthcare providers, employers and universities with rapid and accurate COVID-19 diagnostic and antibody testing which is essential for reopening businesses and communities.

Summary

The position focuses on clinical documents such as validation protocols, IRB Protocols and clinical study reports (CSRs) and regulatory submissions. This will entail some project management and leadership, working closely with team members to ensure the documents are high quality and completed in a timely fashion, compliant with SOPs, FDA and CGP guidelines, CLIA/CAP requirements, and company goals.

Responsibilities

  • Write, edit and collaborate on development of preclinical, clinical, and sections of regulatory documents (e.g., Clinical Validation protocols, IRB Protocols, clinical study reports, marketing materials.
  • Compile, write, and edit documents covering all phases of clinical research, to include integrated summaries of data, risk/benefit analysis, etc
  • Organize and assist in filing FDA documentation
  • Assist in the analysis, synthesis and presentation of complex information for scientific presentations
  • Distill large amounts of clinical and scientific data into essential elements for graphical display and formulate key messages from clinical study data
  • Provide QC review support as needed and ensure consistency between related documents
  • Coordinate, plan, and manage communications to enable timely review from other authors and reviewers and to function as a collaborative team member
  • Develop and maintain medical writing processes, SOPs, templates, and outlines for key documents

Qualifications

  • BS, MS, PharmD, or PhD in a scientific or medical discipline with relevant experience required
  • 5+ years' experience in the clinical/regulatory writing and editing required
  • Basic to intermediate knowledge of biostatistical and clinical research concepts required
  • Thorough understanding of FDA and CLIA/CAP regulations and guidelines, and AMA editing standards
  • Experience authoring/editing CSRs and other types of clinical regulatory documents (e.g., clinical protocols, Investigator's Brochures)
  • Ability to work collaboratively to coordinate the efforts of team members to complete deliverables
  • Flexible, adapts work style to meet organization needs

Work Location: Work Remotely
Yes

Compensation: TBD

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