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Medical Writer

RRD Biopharma Development is driven to build value for our partners and investors, and ultimately to bring new medicines to patients. Our teams of biopharma development professionals can accelerate drug development, thanks to our unique partnership model. RRD integrates all critical development disciplines including strategy, regulatory, clinical, quality and CMC. We strategize, optimize and execute to ensure efficiency and achieve value.

We are expanding our Medical Writing team and are looking for a full-time Writer for regulatory/medical writing projects, writing and editing documents relating to investigational drug/biologic trials. In this position, the Writer will:

  • Help prepare documents to support investigational drug/biologic trials, including but not limited to:
  • Phase 1 clinical pharmacology and SAD/MAD protocols and clinical study reports
  • Phase 2 and Phase 3 protocols and clinical study reports
  • Nonclinical and clinical summaries for INDs and NDAs/BLAs
  • Regulatory submissions: annual reports, meeting packages, special designation requests (eg, orphan designation, breakthrough designation)
  • Interface with project teams regarding issues related to the preparation of scientifically sound, accurate, and consistent documents that are compliant with applicable regulations
  • Perform quality control (QC) checks on documents to ensure accuracy, consistency, and compliance with editorial standards
  • Perform literature searches and prepare summaries of literature
  • Follow and contribute to department standard operating procedures (SOPs) and other standards relating to medical writing
  • Work with other team members in performing writing, editorial, and QC tasks

The ideal candidate can provide:

  • Bachelor’s degree or equivalent; advanced degree in a science-or health-related discipline preferred
  • Ability to summarize scientific information clearly and concisely with correct grammar and punctuation
  • Proficiency in authoring and formatting documents in Word.
  • Ability to work on several projects at once while balancing multiple timelines
  • Consistent, careful attention to detail and accuracy
  • Ability to successfully collaborate with others and work independently with oversight
  • Excellent organizational skills and strong computer literacy and skills
  • Ability to communicate effectively

If you would like to be a part of our world-class team, please send your resume to ahill@rrdbiodev. Please, no phone calls. Learn more about us at www.rrdbiodev.com.

RRD International LLC is strongly committed to providing equal employment opportunities for all employees and all applicants for employment. For us, this is the only acceptable way to do business. All employment decisions at our Company – including those relating to hiring – will be made without regard to race, color, religion, age, sex, disability or nationality, in compliance with Federal, State and Local laws.

Interested candidates can submit their CV via email to ahill@rrdbiodev.com