Search Jobs

Medical Writer

San Diego Metro Area, CA

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


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

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

Not ready to apply?

Send an email reminder to:

Share This Job:

Related Jobs: