Writers.Work

Remote Medical Writer – Clinical and Regulatory Documentation

Overview
Medical WritingTechnicalFull-timeContractorRemoteSan Jose, CA
San Jose, CA
Remote
Full-time, Contractor
$90,000 - $140,000 yearly
Medical Writing
19 days ago
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Job description

Our team in San Jose, CA is seeking a dedicated Medical Writer to craft clear, concise, and compliant documentation across a variety of therapeutic areas. If you possess a strong scientific acumen and a knack for translating complex data into accessible language, this remote opportunity may be your next career milestone.

What You'll Contribute

  • Author and edit clinical study reports, investigator brochures, and regulatory submissions.
  • Develop compelling marketing materials, slide decks, and abstracts for scientific conferences.
  • Collaborate with cross-functional teams including clinical development, medical affairs, and regulatory affairs.
  • Ensure documents are in line with FDA guidelines and industry best practices.
  • Participate in the literature review process and maintain current knowledge of relevant medical advancements.
  • Manage multiple projects and meet tight deadlines in a fast-paced setting.
  • Provide quality control review of documents prepared by other medical writers.

Necessary Abilities

  • A graduate degree in a life sciences discipline (PharmD, PhD, MD, or equivalent) provides the necessary scholarly preparation.
  • Proven success in medical writing, including regulatory documents and publications provides the necessary hands-on expertise.
  • Familiarity with ICH guidelines and other regulatory requirements are also important.
  • A talent for writing, editing, and proofreading detailed technical content demonstrates important communication skills.
  • Capacity to interpret statistical data and present them in an engaging manner is necessary for success.
  • Excellent project management and time-management skills.
  • Experience with electronic document management systems.

Reasons to Work With Us

  • Competitive compensation with performance-based bonuses.
  • Generous paid time off and comprehensive health benefits.
  • Work-from-home flexibility offering an ideal balance.
  • Opportunities for professional growth and continuing education.
  • Collaborative and inclusive work environment supporting work-life balance.
  • Access to cutting-edge technology and resources.
  • Be a part of a meaningful mission that helps to improve the health of patients.

Bonus Traits

  • Experience with a specific therapeutic area.
  • A good track record of publishing scientific manuscripts.
  • Membership in professional medical writing organizations.
  • Proficiency in multiple software applications utilized in medical writing.