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Job Requirements of Technical Writer:
-
Employment Type:
Contractor
-
Location:
New Brunswick, NJ (Onsite)
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Technical Writer
Careers Integrated Resources Inc
New Brunswick, NJ (Onsite)
Contractor
Job Title: Technical Writer
Location: New Brunswick, NJ – 50% Remote role
Duration: 12 Months+ (Possibility of Extension)
Pay rate: $44.29/Hr. On w2
Job Description:
Primary Responsibilities:
Competencies & Experiences:
Travel: Occasionally to other local NJ sites for larger team meetings.(2-3 times a year)
#sczr2
Location: New Brunswick, NJ – 50% Remote role
Duration: 12 Months+ (Possibility of Extension)
Pay rate: $44.29/Hr. On w2
Job Description:
- The Technical Writer will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline 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, 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 across CTD pipeline assets.
- 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.
- Ensures 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 CTD 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:
- Required Bachelor’s degree in Biology or related discipline with a minimum of 2 years’ experience
- Familiarity and understanding of regulatory requirements and guidance 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.
Travel: Occasionally to other local NJ sites for larger team meetings.(2-3 times a year)
#sczr2
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