Technical Writer and Document Analyst - TechDigital
Warren, NJ
About the Job
Job Description:
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.
Primary Responsibilities:
• 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
Competencies & Experiences
• 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
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.
Primary Responsibilities:
• 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
Competencies & Experiences
• 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
Source : TechDigital
