Senior Medical Writer

Location
Rockville, Maryland
Salary
Competitive
Posted
Nov 07, 2019
Closes
Dec 07, 2019
Ref
2132
Function
Other
Industry
Science
Hours
Full Time
The Emmes Company, LLC is searching for a Senior Medical Writer located in our Rockville, Maryland or Frederick, 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 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.

Primary Purpose

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.

Responsibilities

  • 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


Experience

  • Bachelor's degree
  • 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


Desired

  • 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.

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