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Medical Writer

San Diego Metro Area, California

Post Date: 05/17/2017 Job ID: JN -052017-19080 Industry: Medical Writing - Clinical

General Summary:

This position writes clinical and regulatory documents. Initial project is to write a Phase 3 protocol in collaboration with a small study team. Additionally, the position will potentially write one or more briefing documents for regulatory agency meetings and support other medical writing projects as needed.

Responsibilities and Duties:
  • Author, co-author, critically edit, and format clinical and regulatory documents including protocols, CSRs, Investigator Brochures, briefing documents, marketing applications, and other regulatory submissions;
  • Manage medical writing timelines for assigned projects;
  • Schedule, organize, and lead document review meetings;
  • Serve as the functional area expert on assigned projects and advise such teams on content, format, and style-guide requirements for documents;
  • Willingness to perform miscellaneous job-related duties and accept new assignments as needed.

Knowledge, Skills, Abilities and Qualification Requirements:
  • Degree in the life sciences required (BS, MS, PhD, or Pharm D);
  • 2 years or more of medical writing experience in the pharmaceutical or biotechnology industry, including protocol writing experience;
  • Excellent writing skills coupled with knowledge of the drug development process and regulatory guidelines;
  • Effective collaborator with ability to foster strong working relationships and build consensus among colleagues on cross-functional teams;
  • Initiative and ability to handle a variety of projects simultaneously;
  • Excellent interpersonal and communication skills;
  • Knowledge of clinical and regulatory documents and publication practices including GCP, ICH, ICMJE, and CONSORT;
  • Expert user of Microsoft Word and experience using templates
  • Key Competencies:
    • Professionalism and customer service orientation
    • Communication skills - written and verbal
    • Planning, organizing and multi-tasking
    • Prioritizing and time management
    • Problem assessment and problem solving
    • Information gathering and information monitoring
    • Attention to detail and accuracy
    • Flexibility, adaptability and teamwork

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