Technical writer in New Brunswick, New Jersey

Location

New Brunswick, New Jersey

Job Type

Full-time

Salary

$33.03 – $41.95/hr

Company

Integrated Resources, Inc

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) #sczr2