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Sr. Medical Writer Job Details

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Job Ref:  1126
Sector:  Pharmaceutical and Medical Device
Job Type:  Full Time
State:  Washington (WA)
City:  Seattle
Post Code:  Sep 19, 2011
Job Description:  Acucela is a clinical-stage, privately held bio-technology company focused on developing new drug therapies for blinding eye diseases such as age-related macular degeneration (AMD), dry eye, glaucoma, Stargardt disease, diabetic retinopathy and retinopathy of prematurity. The Company offers competitive compensation, a team oriented environment, and career growth opportunities.

Sr. Medical Writer - A regular full time position is available immediately at Acucela Inc., in Seattle, Washington. This position will report to the Director of Medical Writing and be responsible for the following:
Primary Responsibilities
Prepare protocols, clinical study reports, investigator brochures, clinical and nonclinical study documentation and other regulatory documents as required according to SOPs and regulatory agency guidelines.
Prepare publications (manuscripts, abstracts, posters, oral presentations, etc.) and oversee the publication development process, working with authors, thought leaders, and other cross-functional publication team members.
Review and QC key regulatory documents as needed, including but not limited to integrated summaries of safety, clinical study reports, publications, and briefing packages.

Requirements

Qualifications and Requirements
Advanced degree in a primary science such as M.S., Pharm.D., Ph.D., preferred.
Minimum 3 years experience as a Medical Writer in the pharmaceutical industry
Proficient in understanding, evaluating, and interpreting scientific/clinical/statistical data.
Able to manage multiple projects within established timelines; set priorities; and adjust to changes in schedule/workload.
Highly motivated to keep current with developments in pharma industry, regulatory agencies/guidelines, and company SOPs.
Experience in ophthalmology highly desirable.
Experience preparing nonclinical documents highly desirable.
Excellent interpersonal skills; ability to work cooperatively within a team as well as independently.
Excellent command of the English language (written and spoken); proficiency in AMA style.
Exceptional communication skills; ability to communicate effectively with all levels of the organization.
Intermediate to advanced skills in Excel, Word, PowerPoint, Share Point and MS Project.
No phone calls please. Only those candidates chosen for interview will be contacted. Send resume to Acucela Inc., Attn: Recruiter via email to career@acucela.com, or via facsimile at 206.805.8301. Only direct applicants will be accepted, no recruiters please. Acucela Inc. is an EOE.

09/20/2011
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