Careers

Job Description

Senior/Principal Medical Writer

Responsibilities

  • Writes and edits documents relating to investigational drug/biologic trials
  • Performs literature searches and prepares summaries of literature
  • Maintains knowledge of current regulations and regulatory guidance relevant to medical writing department
  • May serve as a technical lead on a regulatory/medical writing project; works with project teams and as needed will participate in cross-functional team meetings
  • Reviews documents written by internal staff, external consultants, or contract writers
  • Mentors/oversees junior staff in performing writing, editorial, and QC tasks
  • Assists senior staff to prospectively identify program needs and track team progress
  • Manages contract writers as needed, including oversight of timelines and review/QC processes
  • Contributes to the development of department SOPs and standards
  • May perform QC checks on documents relating to regulatory submissions
  • May work with regulatory staff to publish and submit documents to Regulatory Authorities/Sponsor

Qualifications

  • Bachelor’s degree or equivalent, advanced degree preferred
  • 7 years or more of relevant medical/technical writing experience, at least 6 of these writing in a pharma/biotech/Contract Research Organization environment)
  • Careful attention to detail and accuracy
  • Ability to collaborate with others and work independently with minimal oversight
  • Thorough knowledge of regulations relevant to medical writing/ area of expertise (eg, US Food and Drug Administration requirements and ICH guidance for drugs/biologics, and electronic CTD)
  • Ability to summarize scientific data
  • Ability to communicate effectively
  • Ability to make oneself understood at multiple levels in the organization and in difficult situations
  • Ability to work on several projects at once while balancing multiple timelines
  • Excellent organizational skills and good computer literacy and skills
  • Good interpersonal and problem-solving skills

Apply

From backgrounds in pharma/biotech, CRO management and at the FDA, the RRD team delivers a unique combination of knowledge, experience and strategic thinking to product development, across all major classes and therapeutic areas.

If you would like to be a part of our world-class team, please complete the form below and attach your resume.

All fields required.