Medical Writer

  • location: Lexington, MA
  • type: Contract
  • salary: $65 - $79.30 per hour
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job description

Medical Writer

job summary:
The Standard Operating Procedures (SOP) Technical Writer is responsible for working with Subject Matter Experts (SMEs) to prepare new or changes to existing Policies, SOPs, and Work Instructions as part of an overall document harmonization and integration project. The SOP Writer is responsible for implementing the document workflow process as a formal written procedure as well as being responsible for supporting the development and revision of procedures by applying document standards, criteria and adhering to timelines. Emphasis will be to address procedures from Global Medical Affairs, Global Drug Safety, Global Regulatory Affairs, Research, Non-Clinical Development, Quality Assurance and Compliance and Global Clinical Development Operations.

location: Lexington, Massachusetts
job type: Contract
salary: $65.00 - 79.30 per hour
work hours: 9 to 5
education: Bachelors
  • Supports the full procedural document lifecycle for Policies, SOPs, Work Instructions (WIs) and Forms by serving as a SOP Writer
  • Works with document owner, global process owner and SMEs to implement agreed upon procedural development applying appropriate document standards and criteria, ensuring terminology consistency across documents
  • Collects input from stakeholders and consolidates comments, resolving conflicts collaboratively
  • Translates process maps or other process representations and applies them to SOP procedures wording
  • Contributes to the development and maintenance of up-to- date SOP Writer procedures so that the process is used and consistently applied by all SOP Writers
  • Works with functional area SMEs to develop cross-functional process models
  • Contributes to the maintenance and updates to the SOP harmonization tracking spreadsheets and timelines, as assigned
  • Performs other duties, as assigned
  • Displays the ability to manage customer expectations
  • Demonstrates proactive thinking and actions
  • Familiar with cross-functional customer service techniques
  • Ability to multi-task in a fast-moving environment
  • Maintains tracking spreadsheets and timelines as assigned
  • B.S in a scientific or allied health field (or equivalent degree)
  • 5 years of Research and Development medical writing or Research and Development SOP writing experience in the Biotech, Pharmaceutical, or Medical Device Industry, or relevant comparable background preferred
  • 5 years of Research and Development experience required
  • Experience in working in a GXP environment with emphasis on GCP, GLP, GPV, and GMP
  • Possesses a solid understanding of document standards, criteria and conventions
  • 3+ years document management experience
  • Experience working in a system for collaborative document development
  • R&D Process Modeling/Process Mapping understanding and experience, a plus
  • Technical writing certification a plus
skills: SOP, GCP (Good Clinical Practice), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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