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Medical Writer

San Diego Metro Area, CA

Post Date: 05/17/2017 Job ID: JN -052017-19082 Job Type: Other

Description

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:
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

Education:
Degree in the life sciences required (BS, MS, PhD, or Pharm D);


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