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Senior Medical Writing Quality Control Review Associate
at Vertex
Boston, MA

Senior Medical Writing Quality Control Review Associate
at Vertex
Boston, MA

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Description

Job Description:

*open to remote location but Boston is preferable

We are seeking a Senior Associate to join our Medical Writing team in Boston. As a Senior Associate you will be responsible for quality control (QC) review of Medical Writing (MW) documents. You will perform advanced fact checking, content, editing, and formatting of regulatory and clinical study documents according to Vertex and regulatory guidelines to produce high-quality, scientifically accurate documents. Working independently, you will provide key input to business process development, act as a mentor within the department, and may also support cross-functional initiatives. (This is not a writing position.)

Key Responsibilities:

  • QC review of regulatory and clinical study documents, including study reports and protocols
  • Uses the electronic data management system (eDMS) to track, route, file, maintain, and archive MW documentation, including clinical study report appendices
  • Acts as a resource for Microsoft Word
  • Regularly interacts with a variety of employees internally
  • Performs high-level information searches in the eDMS and various Vertex document repositories; reviews, analyzes, and recommends or takes action based on data captured
  • Ensures compliance with department, company, and industry regulatory requirements
  • Provides troubleshooting and training to all levels on key MW processes and systems
  • Communicates ideas for new processes and/or business operations for process improvement
  • Leads implementation efforts to change internal procedures and processes as assigned
  • Represents MW department on assigned projects and/or task teams
  • May participate or supervise in the development and implementation of MW strategy for specific business processes and MW initiatives, including work on SOPs, work instructions, templates, and checklists
  • May support MW on programs and cross-functional initiatives
  • May supervise other MW staff
  • Performs other duties as assigned, which may include occasional document writing support

Technical and Communicative Skills:

  • Proficiency in Microsoft Office applications (including Word, PowerPoint, and Excel)
  • Attention to detail related to consistency, grammar, syntax, and scientific accuracy
  • Aptitude for systems applications, including eDMS, PleaseReview, and EndNote
  • Knowledge of the AMA Manual of Style, Good Clinical Practice (GCP), and the drug development process
  • Demonstrated knowledge of regulatory guidelines about clinical documentation
  • Aptitude for and interest in scientific concepts in the biotech/pharmaceutical industries
  • Self-motivated, solves problems, and adapts to new work requests with minimal instruction and guidance, with the ability to prioritize and manage multiple projects; adapts to changing priorities
  • Excellent interpersonal, verbal, and written skills
  • Exercises discretion and discernment to handle routine and unusual situations
  • Consistently displays a high level of business insight when completing assignments and projects
  • Able to provide some leadership on a cross-functional team and work effectively in a matrix environment
#LI-SO1

Qualification:

  • B.S. (or equivalent degree) and 4+ years of relevant work experience
#LI-SO1

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