Senior Medical Writer

Senior 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 Senior Medical Writer will be responsible for authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to support other clinical communication efforts, including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.

Responsibilities
  • Independently writes Investigational New Drug (IND), Biologics License (BLA) applications, amendments, annual reports, New Drug Applications (NDA) and/or Marketing Authorization Applications (MAA), pivotal study reports, Integrated summaries of safety and efficacy, Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, and other documents to support global product development
  • Leads 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
  • Leads the development and authoring of abstracts and slides or posters presenting clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewed journals including direct collaboration with internal and external authors
  • Closely interacts with biostatistics and programming departments in the development of statistical analysis plans and the design of statistical outputs demonstrating advanced problem-solving ability
  • Drives the document preparation process, drafts and distributes documents for review, and incorporates/resolves comments with all reviewers
  • Leads internal cross-functional document development meetings to ensure issues are resolved
  • Represents medical writing on study/project teams and contributes to program strategy, through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments
  • Maintains current therapeutic and project operation knowledge
  • Staff mentor and role model for new and or junior writers to the team
  • Leads or participates in the development of medical writing processes and infrastructure development
  • 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

Experience
  • BS/BA/MS/MA degree (prefer in scientific or health-related field) and 4-5 years Or PhD/PharmD degree (prefer 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 Or
  • Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data
  • Understanding of clinical product development, clinical research, clinical study design, biostatistics, medical terminology, research methodology, the regulatory environment including FDA/ICH guidelines, and principles of GXP/ICH/CTD, and other global standards
  • Develops expert knowledge of US and international regulations, requirements, and guidance associated with clinical regulatory document preparation and submissions
  • Expertise with medical terminology and/or research methodology
  • Ability to work collaboratively and coordinate the efforts of team members to resolve comments and produce a final high-quality document
  • 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
  • Experience working in a fast-paced, cohesive, collaborative team-oriented work environment
  • Experience using Common Technical Document content templates
  • Expert knowledge of current electronic document management systems and information technology


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.

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