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Senior Medical Writer Job Details

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Job Ref:  1112LM-01
Sector:  Pharmaceutical and Medical Device
Job Type:  Full Time
State:  Washington (WA)
City:  Bothell
Post Code:  Dec 21, 2011
Job Description:  Seattle Genetics is currently seeking a Senior Medical Writer to create and revise documents for submission to the FDA and other regulatory agencies and for internal and external communication of study data, including publication in peer-reviewed scientific journals.

Responsibilities:
Write and edit clinical study reports, study protocols, investigators brochures, clinical data summaries, and other medical/regulatory documents. Serve as the primary medical writing representative on project teams and work closely with personnel from clinical, regulatory, and scientific departments. Develop and implement templates and formats for standardization of documents. Participate in the development of scientific manuscripts and abstracts reporting clinical study data, as well as slide and poster presentations.

Requirements

Bachelors degree in a life sciences discipline
Minimum of 5 years biopharmaceutical industry experience
Extensive experience preparing clinical regulatory documents
Experience reporting clinical study results in scientific publications
Solid understanding of FDA/ICH guidelines and GCPs
NDA/BLA/MAA submission and eCTD experience preferred
Strong written and verbal communication skills
Expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred
Ability to coordinate and prioritize multiple projects in a fast-paced environment
Background in oncology drug development is a plus

Seattle Genetics is an equal opportunity employer.

12/23/2011
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