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Medical Writing and Regulatory Communications

Medical Writing and Regulatory Communications

Medical Writing and Regulatory Communications

Job Title: Medical Writing and Regulatory Communications

Department: Regulatory Affairs

Location: Durham, NC

JOB SUMMARY:

The purpose of this role is to write, or coordinate the preparation of, all clinical, regulatory and scientific documents intended to support clinical and regulatory deliverables for BioCryst drug development project teams. The scope of the role includes authoring, review, and quality assurance check of documents, and management of external medical writers.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Author or coordinate the authoring of the following Clinical Documents:
    • Study Protocols
    • Clinical Study Reports
    • Clinical Study Summaries (for posting to study registries)
  • Author or coordinate the authoring of the following Regulatory Documents:
    • Common Technical document (CTD) clinical and nonclinical sections for IND, NDA and MAA documents
    • Briefing Documents for Regulatory Interactions, e.g., FDA Meetings, EMA Scientific Advice
    • Responses to Regulatory Agency questions
  • Author or coordinate the authoring of the following multidisciplinary documents:
    • Investigator Brochures
    • Orphan Drug Designation Requests
    • Manuscripts and posters, including support for primary author, writing or coordinating first drafts, managing internal and external reviews and journal submission
  • Manage external medical writing resources
  • Organizes Framework Meetings prior to the initiation of key clinical or regulatory documents to ensure alignment on essential insights and scope
  • Coordinate the review and quality check of all documents
  • Work with Clinical Development, Biostatistics, Safety, Regulatory Affairs and Project Management to ensure document preparation timelines are consistent with Program goals
  • Provide training to internal staff and external resources on the use of authoring templates, bibliographic citation software, and review tools
  • Develops and maintains a BioCryst Authoring Guide for all the documents noted above

REQUIRED EDUCATION/EXPERIENCE/SKILLS:

Bachelor's degree in a life science-related discipline with advanced degree preferred. Five or more years experience in Medical Writing in the Biopharmaceutical industry, with experience supporting NDA filings.. Regulatory writing experience is preferred.

Minimal Requirements:

  • Ability to work without close supervision
  • Direct management experience or experience coordinating external resources
  • Excellent written and verbal communication skills
  • Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
  • Ability to multi-task and complete assignments on time
  • Excellent problem-solving capabilities and organizational skills
  • Knowledge of medical, pharmaceutical, and clinical research concepts
  • A high degree of familiarity with statistical and data output
  • Expert level skills in relevant computer software including Microsoft Word, and familiarity with bibliographic citation tools and software
  • Knowledge of the methods, techniques, and procedures of medical writing tasks
  • Prior clinical protocol and CSR writing experience
  • Prior experience with documents for submissions in electronic Common Technical Document (eCTD) format
  • Detailed and experienced-based understanding of applicable regulations, and the CTD structure

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local laws.

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