Documentation Associate Nonclinical Writing and Documentation Position Description
- Accountabilities Formatting and document management activities for nonclinical studies and summary sections, and electronic archiving. Template maintenance.
- Supports drug development through production, monitoring and archiving of nonclinical protocols, reports and documents for regulatory filings. Primary responsibilities include: coordinating documentation for worldwide regulatory submissions; report level publishing, eCTD hyperlinking and QC checks, oversight and /or technical support of nonclinical document preparation including electronic submissions.
- GLP nonclinical study protocol and report document life cycle coordination and/or preparation.
- Regulatory submission coordination
- General quality compliance.
- AS/BS (preferably in technology, sciences or information-related field) recommended. Minimum 2 years experience in a regulated environment with hands-on experience in document management, submission and/or large-volume document preparation. A team player with excellent communication skills and advanced computer literacy is required. Experience in biological research and development is preferred. Proven ability to work independently and effectively handle multiple projects.
- Strong knowledge of word processing applications, database structure, multiple computer applications: electronic document management systems (Documentum or similar applications), EndNote, Oracle, SharePoint.
- Ability to work on several documents at the same time, high attention to detail and accuracy, ability to consistently hit deadlines, excellent written and oral communication skills.
- High level of competency required in teamwork for departmental and cross-functional project teams.
- Fundamental knowledge of worldwide regulatory submissions guidances a plus.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.