Medical Writer

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Medical Writer

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Medical Writer, under supervision of senior writers, writes, revises, edits, and performs quality
control for clinical research and scientific communications documents.

  • Independently writes documents for regulatory submissions, including but not limited to investigator brochures, protocols, device summaries, clinical study reports, and safety reports for assigned projects under the direction of senior writers
  • Contributes to the development and authoring of clinical protocols, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filings in collaboration with clinical study teams
  • Reviews and understands statistical analysis plans and statistical outputs
  • Works with internal teams to conduct literature searches, write literature reports, maintain the literature database, and prepare literature reviews
  • Participates in and contributes to document review meetings with internal teams to ensure issues are resolved
  • Works collaboratively to resolve comments and produce a final high-quality document under the supervision of senior writers
  • Provides quality control review of various regulatory and medical communications documents and reviews draft publications for accuracy and continuity with previously published work and submitted regulatory documents
  • Develops an understanding of US and international regulations, requirements, and guidance associated with clinical regulatory document preparation and submissions
  • Assists senior staff with the preparation of document review timelines
  • Contributes to the overall development and approval process for assigned documents within timelines, including documentation generation, initiation of review process, discussions on proposed revisions, and document completion in collaboration with other study team members under the direction of senior staff
  • Contributes to the development of processes and tools for the medical writing group
  • Represents medical writing on project teams and participates in interactions including provision of scientific background information as needed
  • Maintains current therapeutic and project operation knowledge
  • May provide task-specific mentorship to junior staff
  • Develops or maintains current knowledge of relevant software and technology (MS Project, MS Office [Word, Excel, PowerPoint, Outlook], SharePoint, Adobe Acrobat, EndNote, and eCTD authoring templates)
  • Other duties as assigned

  • BS/BA/MS/MA degree, preferably in scientific or health-related field and 2 years of previous writing experience working on clinical and regulatory submissions in the pharmaceutical, biotech, device, medical communications, or CRO industries
  • PhD/PharmD degree, preferably in scientific or health-related field and no previous experience required
  • Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data
  • Demonstrated understanding of clinical product development, clinical research, clinical study design, biostatistics, medical terminology, research methodology, the regulatory environment including FDA/ICH guidelines, principles of GXP/ICH/CTD, and other global standards
  • Familiarity with medical terminology and/or research methodology
  • Independently motivated with good problem-solving skills allowing analysis, synthesis, and compilation of data from a broad range of disciplines
  • Well-organized with demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines
  • Ability to work in a fast-paced, cohesive, collaborative, team-oriented work environment

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Unlimited Approved Leave

  • Tuition Reimbursement

  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US

  • Maternal/Paternal Leave

  • Casual Dress Code & Work Environment


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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