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Technical writer

Integrated Resources, Inc

New Brunswick, NJ

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JOB DETAILS
SALARY
$33.03–$41.95 Per Hour
SKILLS
Adjudication, Analytical Development, Best Practices, Biology, Biotech and Pharmaceutical, Clinical Practices/Protocols, Communication Skills, Computer Skills, Cross-Functional, Data Management, Detail Oriented, Document Management, Documentation, GPS (Global Positioning System), Logistics Management, Logistics Processes, Mentoring, Microsoft Excel, Microsoft Office, Microsoft SharePoint, Microsoft Word, Negotiation Skills, Organizational Skills, Presentation/Verbal Skills, Process Development, Process Improvement, Process Management, Product Development, Project Portfolio Management (PPM), Project/Program Management, Publications, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Staff Training, Team Lead/Manager, Technical Delivery, Technical Operations, Technical Writing, Time Management, Writing Skills
LOCATION
New Brunswick, NJ
POSTED
22 days ago
Job Title: Technical writer
Location: New Brunswick NJ/ PPK NJ – Hybrid (50% Onsite)
Duration:12 months( possibility of extension)
Work Schedule: Monday - Friday(normal business hours)
Payrate: $33.03-41.95/hr. on W2
 
Job Description:
  • The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development (CTD) Project and Portfolio Management Office (PMO).
  • This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for a late-stage clinical cell therapy program.
  • This role requires effective collaboration across technical functions to deliver on timelines for submissions.
  • The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences across CTDO.
  • The successful candidate will work effectively in cross-functional project teams to accomplish company goals.
 
Primary Responsibilities:
  • Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports.
  • Plan and facilitate submission kick-off for clinical regulatory submissions.
  • Manage the logistical process and detailed timeline for regulatory submissions.
  • Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.
  • Provide input and scientific oversight for content generation for Module 2.3 and 3.
  • Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
  • Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections.
  • Ensure content clarity/ consistency in messaging across dossier.
  • Facilitate and manage the data verification process.
  • Assist with dossier creation and system compliance for regulatory submissions
  • Coordinate response authoring, review and data verification to queries from HA for submissions.
  • Track upcoming submissions and ongoing submission progress
  • Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker.
  • Represent Tech Writing and Document management in cross-functional CMC teams as required.
  • Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions.
  • Collaborate with external suppliers as needed for submission content and review.
  • Support and implement continuous process improvement ideas and initiatives.
  • Train others on procedures, systems access and best practices as appropriate.
  • Mentor and train employees on the document management process
  • Work independently under supervision and collaborate with other teams.
 
Competencies & Experiences
  • Bachelor’s degree or equivalent in Biology or related discipline with a minimum of 2 years’ experience (4-7 years for senior level).
  • Familiarity and understanding of regulatory requirements and guidances pertaining to CMC documentation is preferred; Cell therapy CMC experience required.
  • Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred.
  • 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 computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication.
  • Experience in bio tech/pharma e2e product development required. Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
  • Take ownership of the section – formatting, language check, connections to other sections / tables.
  • Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy and GPS organization.
 
Travel: Occasionally to other local NJ sites for larger team meetings.(2-3 times a year)
 

About the Company

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Integrated Resources, Inc

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