Stage 4 Solutions
Technical Writer– Pharma (Hybrid – New Brunswick, NJ)
Stage 4 Solutions, New Brunswick, New Jersey, us, 08933
Technical Writer– Pharma (Hybrid – New Brunswick, NJ)
We are seeking a Technical Writer – Pharma for our global pharmaceutical client. You will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO). The focus of the role is to deliver 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. This is a 40-hour per-week, 12-month contract (extensions possible), 50% onsite at the client’s office in New Brunswick, NJ. Work Schedule: Mon-Fri (normal business hours). Travel occasionally to other local NJ sites for larger team meetings (2-3 times a year). This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered. 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. 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. Facilitate and manage the data verification process. 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. Requirements 2+ years of experience with 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. 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. Bachelor’s degree in Biology or related discipline is required. Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics. Compensation: $42/hr. - $44.29/hr.
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We are seeking a Technical Writer – Pharma for our global pharmaceutical client. You will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO). The focus of the role is to deliver 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. This is a 40-hour per-week, 12-month contract (extensions possible), 50% onsite at the client’s office in New Brunswick, NJ. Work Schedule: Mon-Fri (normal business hours). Travel occasionally to other local NJ sites for larger team meetings (2-3 times a year). This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered. 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. 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. Facilitate and manage the data verification process. 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. Requirements 2+ years of experience with 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. 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. Bachelor’s degree in Biology or related discipline is required. Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics. Compensation: $42/hr. - $44.29/hr.
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