Regulatory Medical Writer - Contractor
premier-research
 Atlanta, GA
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. We’re looking for a talented and energetic -- Contract Regulatory Medical Writer-- to join our team! Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

Position Summary:

Responsible for writing Clinical Study Reports (CSRs), Protocols, Investigator Brochures (IBs), as well as a variety of other regulatory documents including, but not limited to, Investigational New Drug Applications (INDs) and New Drug Applications (NDAs), manuscripts, and/or poster, slide, or oral presentations.

RESPONSIBLITIES:

  • Writes, edits, and performs quality control (QC) reviews for CSRs, protocols, and IBs
  • Writes Integrated Summaries of Safety and Efficacy (ISS and ISE), New Drug Applications (NDAs) and other regulatory documents necessary for regulatory submission
  • Writes and develops manuscripts and/or posters for publication
  • Creates slides for oral presentations
  • Creates in-text tables and word processing
  • Compiles document appendices, attachments, etc.
  • Reviews draft case report forms (CRFs), statistical analysis plans (SAPs), and blinded data listing reviews prior to database lock and provides feedback to the team when appropriate
  • Reviews documents generated by other medical writers in the department and provides constructive feedback (editing as needed)
  • Conducts background research as necessary for each assigned project, including literature searches
  • Works on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and sponsors
  • Participates in document review meetings with the sponsor to determine the most accurate and appropriate protocol design or interpretation of study results
  • Interprets and trains other staff members regarding current regulatory guidelines pertaining to regulatory documents
  • Interprets scientific literature
  • Ensures timeline adherence for each assigned project
  • Facilitates a team approach for each assigned project
  • Provides project status updates on a regular basis
  • Carries out contractual obligations for each assigned project based on the sponsor proposal
  • Demonstrates an understanding of experimental methods and research design
  • Attends meetings (proposal, kickoff, etc.) with prospective sponsors when necessary
  • Takes the lead for writing complicated assignments
  • Assists in the creation of study templates, review forms, and guidance documents

Experience:

  • 6+ years experience in medical/technical writing
  • 4+ years experience in medical/technical writing if PhD
  • Experience with medical device-related documentation and regulation is preferred.
  • This is a remote-based as-needed contract position.  

Education (Degree) or certifications:

  • Bachelor’s degree in the medical sciences, journalism, or English (MS or PhD preferred)