Medical Writer/Sr. Medical Writer

Excellent medical writing opportunity in beautiful Seattle. Growing biotech has an immediately opening for a Medical Writer or Sr. Medical Writer to join their team.  Competitive compensation & benefit packages offered, including matching 401K program, stock options and tuition reimbursement.


Responsibilities:

*  Write, rewrite, and edit study reports, investigator brochures, study protocols, and clinical/preclinical sections of INDs and BLA/CTD in collaboration with research scientists, medical experts, and statisticians. * Participate in the development of scientific manuscripts and abstracts describing clinical/preclinical study data, as well as slide and poster presentations.
*Serve as the primary medical writing representative on cross-functional project and clinical study teams.
*Develop detailed document timelines specifying draft and revision periods.
*Develop formats, templates, and processes for regulatory document production in support of electronic submissions.
*Conduct literature reviews and prepare topic-specific summaries.
*May supervise the work of contract medical writers and editorial assistants.

The successful candidate will have:

*Master's degree or higher in a life sciences discipline
*2-5+ years of medical writing experience in the biotechnology/pharmaceutical industry
*Expert ability in Microsoft Word, Excel, PowerPoint and Outlook, as well as scientific graphing applications.
* Knowledge of good document management practices and document management software applications.
* Ability to interpret and report complex scientific data in an organized and accurate fashion
* Familiarity with GCP and FDA/ICH guidelines
* Strong written, oral & interpersonal communication skills

Please send resume in a word format attachment to execquest@comcast.net or contact Lisa FitzGerald  @ 877-467-4099 for more information