Senior Medical Writer
The Emmes Corporation is searching for a Senior Medical Writer located in our 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.
The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership in research, training, and education to prevent and treat heart, lung, blood and sleep disorders. The NHLBI is convening a Cure Sickle Cell Disease Initiative (CureSCi), aimed at finding innovative ways to support discovery and development of efficacious genetic therapeutic approaches and bring them to scale in clinical populations to accelerate finding curative treatments for Sickle Cell Disease (SCD). The NHLBI is working with The EMMES Corporation to establish a Coordinating Center (CC) for the CSCI and to engage key staff of this initiative.
In collaboration with the project team, the Senior Medical Writer is responsible for attending Cure Sickle Cell Initiative meetings and drafting minutes, as well as working with internal and external members of the Cure Sickle Cell Initiative to research and create scientific documents and ensure their compliance with regulatory and professional guidelines.
- Drafts, edits, and ensures quality of meeting minutes and other study documents from all Cure Sickle Cell Initiative meetings
- Coordinates finalization of report elements, establishes and maintains timelines, maintains version control, and ensures 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
- Compiles and distills information from qualitative outreach into summary reports
- 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 Trial 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 5 years’ experience writing and preparing scientific and medical documentation
- Knowledge of medical terminology, with an understanding of hematology terminology preferred
- 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.Back Email Apply Now