Senior Medical Writer

The Emmes Company, LLC ("Emmes") is searching for a Senior Medical Writer . Emmes provides flexibility for office location or remote work preference.

Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over nine hundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

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


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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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