Medical Writer II

Junto HLS has been exclusively retained by a Boutique CRO to recruit a Medical Writer II.

Please note This is an impactful position, will work with a former Deputy Director from the FDA and the opportunity should be exciting for anyone looking for an entrepreneurial career/ growth opportunity vs. just another job.

Position Overview:

    • FULL-TIME Position (not contract)
    • Supports medical writing activities for investigational new drugs and biologics and combination products
    • Participates in project teams and may lead specific writing or QC tasks
    • Writes and edits documents relating to investigational trials, including the following: protocols, protocol amendments, Investigator Brochures, study reports, patient narratives, IND sections, IND annual reports, other regulatory submissions
    • Performs QC checks on documents relating to regulatory submissions
    • Performs literature searches and prepares summaries of literature
    • Interacts with internal regulatory staff and external vendors to facilitate publishing and submission of regulatory documents
    • Assists senior staff in the development and updates to department standard operating procedures, forms, and guidelines
    • Mentors/oversees junior and administrative staff in performing editorial and QC tasks

Location(s):

  • Greater Washington DC Area

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.