Kateric
Published
January 11, 2022
Location
Remote
Category
Other  
Job Type
Work Setting
Remote / Home-based

Description

We are looking for experienced regulatory writers to join our dynamic, collaborative team to engage with biopharmaceutical clients and prepare clinical and safety regulatory documents. This is a remote, long-term contract opportunity with an expected average commitment of 30-40 hours per week, with the potential for additional hours depending on project needs

We currently have opportunities for medical writers to author clinical and safety documents for pharmaceuticals and devices. Our writers are responsible for driving the development of each deliverable including de novo writing (to varying levels) and/or managing stakeholder contributions, ensuring adherence to client styles and formatting, managing stakeholder expectations, and ensuring timeline integrity across a wide variety of document types (e.g., Protocols, Briefing Packages, Investigator’s Brochures, Clinical Study Reports, Development Safety Update Reports, CTD module documents, clinical evaluation plans/reports, etc.).
We provide the training, tools, infrastructure, and support needed for our writers to be successful. We also provide significant development opportunities for our team members resulting in exposure to a wide variety of document/product types and therapy areas.
U.S.- and E.U.-based candidates must be available to work during regular business hours in their respective time zones. Completion of a writing assessment is a screening requirement as part of the recruiting process.

Additional Responsibilities

  • Represent medical writing as part of a global, cross-functional team and work independently to successfully drive the production and development of each deliverable following the client business process
  • Ensure adherence to GCP, ICH guidelines, SOPs, and client templates and style guides
  • Interpret and present clinical and scientific data
  • Manage contributions from multiple, global cross-functional stakeholders
  • Manage and communicate timelines to stakeholders
  • Manage the review, adjudication, and finalization (approval, publishing) of each deliverable, as applicable
  • Provide frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real-time
  • Develop strong, lasting relationships with client teams that encourage organic new business growth

Background

  • Minimum BS within a relevant scientific discipline; advanced degree preferred
  • 3+ years of experience with medical writing, preferably in the pharmaceutical industry

Knowledge

  • Solid understanding of the drug/device development process, including the documents that are required at each stage and the roles of other functional areas and group interdependencies within research operations
  • Knowledge and understanding of Good Publication Practices and clinical research process, including ICH GCP and FDA regulation
  • Mastery of the English language and relevant scientific terminology

Skills

  • Exceptional written and verbal communication skills
  • Superior attention to detail
  • Project/stakeholder management
  • Experience working with templates and style guides
  • Skilled (mastery level) in the following technologies:
    • Microsoft Suite (Word, PowerPoint, and Excel)
    • Adobe Acrobat/PDF software
    • SharePoint
    • Document management systems and associated tools
Apply
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