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Technical Writer – Regulatory CMC Documentation Location: New Brunswick, NJ / Princeton Pike, NJ Schedule: Monday – Friday, Normal Business Hours Work Model: 50% Onsite Required Duration: 12 Months (High possibility of extension based on performance and business needs) Position Summary We are seeking a Technical Writer with experience in Regulatory CMC documentation within the pharmaceutical or biotechnology industry. This role will support regulatory submission activities for a late-stage cell therapy program and will work closely with cross-functional teams including Regulatory Affairs, Process Development, Analytical Development, Quality, and Technical Operations. The ideal candidate will have hands-on experience supporting eCTD regulatory submissions, strong technical writing capabilities, and the ability to manage multiple timelines in a fast-paced environment. Responsibilities • Author, edit, and review Regulatory CMC documentation for regulatory submissions, • Support preparation of dossiers and submission-related documents aligned with regulatory strategy, • Coordinate with SMEs to gather source documentation and ensure timely content delivery, • Assist with eCTD submission preparation and document management activities, • Review technical content for accuracy, consistency, formatting, and compliance readiness, • Track submission timelines, document status, and project milestones, • Facilitate comment resolution and support data verification activities, • Collaborate cross-functionally with Regulatory Affairs, Quality, Technical Operations, and Development teams, • Maintain organized documentation and ensure adherence to submission deadlines Required Qualifications • Bachelor’s degree in Biology, Biotechnology, Life Sciences, or related discipline, • Minimum 2+ years of Technical Writing experience focused on Regulatory CMC documentation within pharma or biotech industry, • Familiarity with eCTD structure and regulatory submission processes, • Strong written and verbal communication skills, • Excellent attention to detail, planning, organizational, and coordination skills, • Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and SharePoint, • Ability to work independently and manage multiple priorities in a deadline-driven environment Preferred Qualifications • Experience supporting IND/BLA submissions, • Cell therapy or biologics experience preferred, • Experience working with cross-functional regulatory and scientific teams, • Familiarity with compliance-ready document formatting and publishing standards

Description The CMC Regulatory Technical Writer II is a designate of the CMC Dossier Development team and participates in Client’s lifecycle management (LCM) programs. They collaborate directly with Client's global business units (GBU) - Specialty Care, Vaccines, General Medicines, and Consumer Healthcare - by contributing to US, EU and rest of world (ROW) dossiers (e.g. NDA, MAA, IND, and IMPD). Key Responsibilities The technical writer develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post-approval regulatory dossiers within pre-established timelines. This includes responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports. Additionally, the technical writer authors and evaluates change controls for global regulatory impact, and is sometimes called upon to author technical reports, position papers, white papers, or SOPs. The technical writer assures regulatory dossier compliance and independently authors high quality CMC content by: • following regulatory guidelines, source documentation, and Client’s templates, • collaborating and coordinating with key stakeholders across the GBU’s, contract manufacturing organizations (CMO) and functional areas such as Quality, Manufacturing, and Global Regulatory Affairs (GRA), • avoiding unsolicited regulatory burden, • supporting the development of regulatory risk mitigation strategies, • maintaining up-to-date knowledge of Client's ways of working, SOPs, and CMC regulations and guidelines, • supporting the planning and preparation of timelines Skills and Experience Candidates must possess Chemistry, Manufacturing and Controls (CMC) and CTD authoring experience (Modules 2 and 3). A background in pharmaceutical manufacturing or quality control/quality assurance is a plus. The candidate must have at least 5 years' experience in the pharmaceutical industry. Expertise with document management systems such as Veeva or Documentum is a plus. A working knowledge of cGMP’s is desired. Experience with MS suite of software applications is expected. This role predominantly focuses on small molecules, and some aseptically manufactured products. Medical device experience is a plus. Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to interact within a multi-disciplinary team. The candidate needs very little supervision, can manage their priorities independently, is highly organized, has a high attention to detail, and is self-motivated. Knowledge of US pharmaceutical Regulations is essential. Exposure to ex-US Regulations is desired, but not mandatory. Education BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field).

Title: Technical Writer Location: New Brunswick, NJ Job Duration: 12 Months+ Possible Extension Shift: Mon-Friday(normal business hours) 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., • 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.

Title: Technical Writer and Document Specialist Work Schedule: Mon-Friday(normal business hours) Duration:12 months( possibility of extension) Location: New Brunswick NJ/ PPK NJ 50% onsite required 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. o Primary Responsibilities: o 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. o Plan and facilitate submission kick-off for clinical regulatory submissions. o Manage the logistical process and detailed timeline for regulatory submissions. o 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. o Provide input and scientific oversight for content generation for Module 2.3 and 3. o Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process. o Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections. o Ensure content clarity/ consistency in messaging across dossier. o Facilitate and manage the data verification process. o Assist with dossier creation and system compliance for regulatory submissions o Coordinate response authoring, review and data verification to queries from HA for submissions. o Track upcoming submissions and ongoing submission progress o Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker. o Represent Tech Writing and Document management in cross-functional CMC teams as required. o Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions. o Collaborate with external suppliers as needed for submission content and review. o Support and implement continuous process improvement ideas and initiatives. o Train others on procedures, systems access and best practices as appropriate. o Mentor and train employees on the document management process o Work independently under supervision and collaborate with other teams. o Competencies & Experiences o Bachelor’s degree or equivalent in Biology or related discipline with a minimum of 2 years’ experience (4-7 years for senior level). o Familiarity and understanding of regulatory requirements and guidances pertaining to CMC documentation is preferred; Cell therapy CMC experience required. o Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred. o Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery. o Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required. o Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication. o 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. o Take ownership of the section – formatting, language check, connections to other sections / tables. o 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) Applicant Notices & Disclaimers • For information on benefits, equal opportunity employment, and location-specific applicant notices, click ___ At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $41.00/daily.

JOB TITLE: Technical writer Location: New Brunswick, NJ (50% Onsite) Duration: 12 months initial (potential extension/potential right to hire) Work Schedule: normal business hours Travel: Occasionally to other local NJ sites for larger team meetings.(2-3 times a year) 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. o Primary Responsibilities: o 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. o Plan and facilitate submission kick-off for clinical regulatory submissions. o Manage the logistical process and detailed timeline for regulatory submissions. o 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. o Provide input and scientific oversight for content generation for Module 2.3 and 3. o Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process. o Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections. o Ensure content clarity/ consistency in messaging across dossier. o Facilitate and manage the data verification process. o Assist with dossier creation and system compliance for regulatory submissions o Coordinate response authoring, review and data verification to queries from HA for submissions. o Track upcoming submissions and ongoing submission progress o Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker. o Represent Tech Writing and Document management in cross-functional CMC teams as required. o Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions. o Collaborate with external suppliers as needed for submission content and review. o Support and implement continuous process improvement ideas and initiatives. o Train others on procedures, systems access and best practices as appropriate. o Mentor and train employees on the document management process o Work independently under supervision and collaborate with other teams. o Competencies & Experiences o Bachelor's degree or equivalent in Biology or related discipline with a minimum of 2 years' experience (4-7 years for senior level). o Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; Cell therapy CMC experience required. o Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred. o Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery. o Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required. o Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication. o 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. o Take ownership of the section – formatting, language check, connections to other sections / tables. o Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy and GPS organization. If hired, you will enjoy the following Eclaro Benefits: • 401k Retirement Savings Plan administered by Merrill Lynch, • Commuter Check Pretax Commuter Benefits, • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro If you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to or call (212)804-7476. Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants. Company: One of Our Clients Job Description: Job title: Regulatory Technical writer Location: New Brunswick, NJ 08903 (50% Onsite) Duration: 12+ Months (Extendable) Hours: Mon-Fri 7am-4pm EST Pay Rate: $39.00 - 41.95/hr on W2 2 Openings Must Haves: 1. Bachelor's degree required, 2. Minimum of 2 year of experience in Technical Writing specifically for Regulatory CMC documentation within the pharmaceutical or biotechnology industry; Familiarity with eCTD structure, BLA regulatory submissions., 3. Strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery., 4. Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required, 5. Strong communication - verbal and written 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) Awards and Accolades: America's Most Honored Businesses (Top 10%) Awarded by USPAAC for the Fastest Growing Business in the US 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020) Fastest 50 by NJ Biz (2020, 2019, 2020) INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list) Top 100 by Dallas Business Journal (2020 and 2019) Proven Supplier of the Year by Workforce Logiq (2020 and 2019) 2019 Spirit of Alliance Award by Agile1 2018 Best of the Best Platinum Award by Agile1 2018 TechServe Alliance Excellence Awards Winner 2017 Best of the Best Gold Award by Agile1(Act1 Group)

Job DescriptionJob 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., • 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, • 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. #sczr2

Job Description SOKOL GxP Services seeking a Technical Writer and Document Specialist to support CMC documentation for a late-stage clinical cell therapy program. This role will sit within the Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional document coordination. The Technical Writer will author and co-author scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC submissions. This includes supporting Module 2.3 and Module 3 content, coordinating source documentation, managing submission timelines, reviewing and adjudicating comments, facilitating data verification, and helping ensure consistency and clarity across the dossier. This position requires close collaboration with Process Development, Analytical Development, Cell Therapy Technical Operations, Quality, Regulatory Sciences, CMC matrix team leaders, project management, document management, and external suppliers as needed. The ideal candidate will be detail-oriented, organized, deadline-driven, and comfortable working in a fast-paced regulatory submission environment. This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence required and occasional travel to other local New Jersey sites for larger team meetings. Requirements Required Qualifications: • Bachelor’s degree required; Biology or related discipline preferred., • Minimum 2 years of experience in technical writing for Regulatory CMC documentation within the pharmaceutical or biotechnology industry., • Familiarity with eCTD structure for regulatory submissions., • Experience supporting CMC regulatory documentation, dossier creation, and submission timelines., • Cell therapy CMC experience required., • Familiarity with CTD Quality sections, including Module 2.3 and Module 3., • Understanding of source documentation requirements for regulatory submissions and how source documents connect to the authoring process., • Strong verbal and written communication skills., • Strong attention to detail, planning, organizational, and negotiating skills., • Demonstrated ability to deliver high-quality documentation within filing deadlines., • Proficiency with Microsoft Office applications, including Word, Excel, SharePoint, and PowerPoint., • Ability to work independently under supervision and collaborate cross-functionally with scientific, regulatory, project management, and document management teams., • BLA regulatory submission experience strongly preferred., • Experience with computer-assisted document preparation tools preferred., • Proficiency in compliance-ready standards for final publication preferred., • Experience in biotech/pharma end-to-end product development preferred. Competitive hourly rate, $: 33.03 – 41.95 (W-2, no C2C option) Working hours: Monday to Friday, regular business hours Hybrid position: 50% onsite required Location: New Brunswick, NJ 12-month contract with possibility of extension Occasional travel to other local New Jersey sites for larger team meetings, approximately 2–3 times per year Health insurance, holiday pay, 401(k), referral bonus program

Job Description Job Title: Technical writer Job ID: 26-002307 Location: New Brunswick, NJ/ Lawrenceville, NJ Duration: 12 Months (possibility of extension) Work Schedule: Mon-Fri 8 am-5 pm (50% onsite required) 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., • 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, • 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. The hourly rate for this position is between $40.00 - $42. 00 per hour. Compensation: Factors which may affect starting pay within this range may include [geography/market, skills, education, experience, and other qualifications of the successful candidate]. Benefits: Sunrise offers ACA-compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations. Contact: Sunny Rajput | | URL: Company DescriptionFounded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.

Writer/Journalist Internship: The role is focused on content creation for BORGEN Magazine or The Borgen Project Blog.

The technical writer assures regulatory dossier compliance and independently authors high quality CMC content by:.