- Full Time
The Emmes Corporation is searching for a Medical Writer located in our Frederick or Rockville, Maryland office. Emmes has offices located at the below locations and throughout the greater Washington, DC area with flexibility for office location preference, dependent upon position.
The Emmes Corporation, established in 1977, is a women-owned private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, 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.
In collaboration with the project team, the Medical Writer is responsible for working with internal and external members of the project team to research and create scientific documents and ensure their compliance with regulatory and professional guidelines.
- Drafts, edits, and ensures quality of Clinical Study Reports (CSRs) and other study documents
- Serves as project manager with internal and external teams for CSRs, coordinating finalization of report elements for FDA submission (Sections 1-16 under ICH guidelines), establishing and maintaining timelines, maintaining version control, and ensuring appropriate final approvals
- As lead or contributing writer/editor, contributes to the research and development of other study documents, including IND Safety Reports, Annual Reports, Protocols, Informed Consent Forms, and submissions to regulatory authorities
- Prepares progress reports for management and funding agencies
- Demonstrates understanding of project and corporate work standards by producing and maintaining work products in compliance with SOPs and project guidance documents
- Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT), project SOP and Compliance/Variance table development, participation of internal and external audits, and professional development activities
- Contributes in the compilation of the Trail Master File (TMF) by maintaining strict version control of materials and tracking of all deliverables and substantive communications
- Other duties as assigned
- Bachelor’s degree with at least 3 years’ experience writing and preparing scientific and medical documentation
- Knowledge of medical terminology
- Ability to integrate tabular data and complex reports into summary reports
- Ability to lead and work effectively with collaborative writing teams, including sponsors, principal investigators, statisticians, clinical trials managers, regulatory affairs specialists, and data managers
- Familiarity with various FDA regulatory documents for clinical research
- Experience preparing a variety of FDA submissions
- PC proficiency and strong skills in Microsoft programs, with advanced Microsoft Word and Adobe Acrobat skills
- Excellent editing and oral communication skills, and the ability to communicate to a wide audience
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs
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The EMMES Corporation 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.