SOP Technical Writer

Location
Rockville, Maryland
Salary
Competitive
Posted
Nov 07, 2019
Closes
Dec 07, 2019
Ref
2229
Function
Other
Industry
Science
Hours
Full Time
The Emmes Company, LLC is searching for a Standard Operating Procedures Technical Writer located in our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides 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 Standard Operating Procedure (SOP) Technical Writer will be responsible for collaborating with cross-functional team members to prepare new and update existing SOPs, works instructions (WIs), and supporting materials.

Responsibilities

  • Oversee the writing, review, and finalization of SOPs and WIs, to provide written, formal process documents and support harmonization of processes across the project
  • Work with VID QA Manager and project stakeholders to establish priorities and timelines for SOP /WI development and review. o Interview subject matter experts, read regulatory guidance, and observe activities to become familiar with current processes
  • Review process maps, checklists, and instructions documents and apply them to development of project SOPs
  • Draft SOPs, Work instructions, and supporting documents and templates according to Emmes standards
  • Recommend SOP/WI revisions, based on reported quality issues and identified areas of risk
  • Coordinate final review and approval of SOPs/WIs with project leadership
  • Assist the VID Training Coordinator in preparing materials to train staff on SOPs and Work Instructions
  • Provide progress reports on SOP/WI development status to VID QA Manager and project leadership
  • In conjunction with the VID QA Manager, coordinate annual review of project specific SOPs and update SOPs in accordance with reviewer comments
  • Other duties as assigned


Experience

  • Bachelor's degree in a scientific discipline or equivalent experience
  • Minimum 2 years of experience in technical or medical writing
  • Experience working in a GxP environment, with emphasis on GCP experience


CONNECT WITH US!!

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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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