Acucela is a clinical-stage, privately held biotechnology company focused on developing new drug therapies for blinding eye diseases such as age-related macular degeneration (AMD), Stargardt disease, diabetic retinopathy and retinopathy of prematurity, as well as dry eye. The Company offers competitive compensation, a team-oriented environment, and career growth opportunities.
Document Management Specialist - A regular full time position is available immediately at Acucela Inc., in Bothell, Washington. This position will report to the Senior Director of Clinical Operations and be responsible for the following:
• Coordinate the routing, review, approval and distribution of regulatory documents.
• Coordinate the receipt and filing of pre-clinical reports and final study reports.
• Develop and maintain Master Files.
• Archive clinical study files, pre-clinical and CMC files.
• Manage period review of controlled documents.
• Maintain master history files in record room.
• Prepare process and status reports for Document Control.
• Coordinate and conduct training of department processes and electronic document management systems.
• Assist with research and retrieval of controlled documents.
Qualifications and Requirements
• AA or equivalent required, Bachelors degree in relevant field, preferred.
• 5-8 years of experience in document management or related area, required.
• Experience setting up, maintaining, and managing a document management system, preferred.
• Experience with electronic document management systems and regulatory submissions, desirable.
• Knowledge of GCP, GMP and GLP, preferred.
• Strong attention to detail with excellent written and oral communication skills.
• Self-motivated and able to function effectively within team.
• Willingness to accept responsibility and accountability.
• Quick Learner.
• Self-management and organizational skills.
• Ability to work independently and multi-task.
• Proficient with advanced Microsoft Word skills required, familiar with Excel.
• Self-starter who takes initiative to do what is needed.
• Diplomatic with client-oriented attitude.
• Applicant must have current legal work authorization to work for any company in the United States
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 425.527.3156. Only direct applicants will be accepted, no recruiters please. Acucela Inc. is an EOE.
- Location: Bothell
- Principals only. Recruiters, please don't contact this job poster.
- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.