The Emmes Company, LLC is searching for a Home-BasedSenior Medical Writer.
The Emmes Company, LLC is a 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 Senior Medical Writer in collaboration with a multidisciplinary project team is responsible for working with internal and external stakeholders to prepare clinical/scientific documents and ensure their compliance with regulatory and professional guidelines. Specifically, the Senior Medical Writer will prepare or assist in the preparation of clinical study protocols, investigator brochures, informed consent and clinical study reports The Senior Medical Writer will maintain/improve the quality of medical writing through mentorship and peer editing/reviews.
Creates interim and final reports for clinical studies as well as a limited number of technical/laboratory reports
Prepares Clinical Study Reports, Pre-Clinical Study Reports, IND Safety Reports, Annual Reports, and Integrated Safety and Efficacy Summaries for FDA submission
Develops clinical protocols, consent forms and related study participant information materials
Prepares materials for proposal development, internal SOPs, literature reviews and background papers, and papers for publication in peer-reviewed medical journals
Maintains documentation required by corporate and project SOPs
Participates in project process improvement and corporate quality assurance activities, project SOP development, and professional development activities
Other duties as assigned
Minimum 4 years of experience writing and preparing scientific and medical documentation
A broad range of training and/or experience within medical and biological sciences
Advanced knowledge of medical terminology
Ability to integrate tabular data and complex reports into summary reports
Familiarity with various Federal Drug Administration (“FDA”) regulatory guidance documents the conduct of clinical research
Knowledge of FDA submissions for investigational products
PC proficiency and mastery in Microsoft programs
Excellent editing and oral communication skills, and the ability to communicate to clinical/technical and lay audiences
Advanced degree in scientific discipline
Experience with regulatory templates used for the preparation of IND, NDA, BLA, IDE, 510K and PMA submissions
Capacity to coach client authors on the development and use of style guides and hyperlinking and bookmarking for electronic publishing
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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.
Telecommuting is allowed.
Internal Number: 2254
About The Emmes Company, LLC
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Frederick and Rockville, Maryland. Emmes is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research.
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