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Documentation Analyst
1 month ago
On-Board Services is hiring a
Documentation Analyst
(HYBRID)
in Seattle, WA
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are Located.
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Position Type: Documentation Analyst
Job Location: Seattle, WA
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance
Compensation: $40-$41.80 (based on experience)
Overview/Summary:
The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development (CTD) Development Operations and Services (DO&S) Portfolio Management Office (PMO). This individual will be responsible for delivering CMC documentation (Dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
This role requires effective collaboration across technical functions to deliver on timelines for submissions. The position interfaces with experts in Process Development, Analytical Development, Manufacturing Sciences and Technology, Operations, Quality and Regulatory Sciences. The successful candidate will work effectively in cross-functional project teams to accomplish company goals.
Qualifications:
• Bachelor’s degree or equivalent in relevant discipline with a minimum of 2 years’ experience (4-7 years for senior level).
• Familiarity with eCTD structure for regulatory submissions is required.
• Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery.
• Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required.
• Experience with regulatory documentum software (CARA, eSub, etc) is strongly preferred along with proficiency in compliance ready standards for final publication.
• Experience in bio tech/pharma development preferred.
• Tech Writing experience in bio tech/pharma preferred.
• Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
Requirements:
• Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high quality technical reports.
• Partner with SME organizations to identify source documents and negotiate delivery of approved technical documents in accordance with project timelines and aligned with CTD requirements and regulatory strategy.
• Collaborate with external suppliers as needed for CTD content and review.
• Provide input and scientific oversight for content generation for Quality modules 2 and 3.
• Review and adjudicate comments, facilitate comment resolution, revise draft sections as needed to ensure content clarity and consistency across dossier.
• Coordinate with CMC matrix team leaders to ensure timely submissions.
• Train others on procedures, systems access and best practices as appropriate.
• Manage the logistical process and detailed timeline for authoring, review and data verification of clinical regulatory submissions.
• Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
• Work independently under supervision and collaborates with other teams.
Additional Responsibilities may include:
• Represent clinical technical writing on cross-functional CMC teams
• Support and implement continuous process improvement ideas and initiatives
• Mentor and train employees on the technical writing processes
• Assist with dossier creation and system compliance
Apply Today
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
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