Job Title: Technical Writer and Document Analyst Location: Warren, NJ, 07059* Hybrid, 50% + onsite Duration: 12 months Schedule: M-F normal business hours, can be flexible
Top Skills: • Outstanding verbal and written communication skills, strong attention to detail. • Planning and organizational skills, demonstrated ability for timely delivery.
Job Description: The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development (CTD) Development Operations and Services (DO&S) 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 an early stage through registrational application. This role requires effective collaboration across technical functions to deliver on submission timelines. The position interfaces with experts in Process Development, Analytical Development, Manufacturing Sciences, Technology, Operations, Quality, and Regulatory Sciences. The successful candidate will work effectively in cross-functional project teams to accomplish company goals.
Primary Responsibilities: • Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high-quality technical reports. • Partner with SME organizations to identify source documents and negotiate the delivery of approved technical documents by project timelines and aligned with CTD requirements and regulatory strategy. • Collaborate with external suppliers as needed for CTD content and review. • Provide input and scientific oversight for content generation for Quality modules 2 and 3. • Review and adjudicate comments, facilitate comment resolution, and revise draft sections as needed to ensure content clarity and consistency across the dossier. • Coordinate with CMC matrix team leaders to ensure timely submissions. • Train others on procedures, systems access, and best practices as appropriate. • Manage the logistical process and detailed timeline for authoring, reviewing, and data verification of clinical regulatory submissions. • Must thoroughly understand the source documentation requirements for regulatory submissions and the correlation to the authoring process. • Work independently under supervision and collaborate with other teams.
Additional Responsibilities may include: • Represent clinical technical writing on cross-functional CMC teams • Support and implement continuous process improvement ideas and initiatives • Mentor and train employees on the technical writing processes • Assist with dossier creation and system compliance
Competencies & Experiences • Bachelor’s degree or equivalent in relevant discipline with a minimum of 2 years experience (4-7 years for senior level). • Familiarity with eCTD structure for regulatory submissions is required. • Outstanding verbal and written 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 regulatory Documentum software (CARA, eSub, etc) is strongly preferred along with proficiency in compliance-ready standards for final publication. • Experience in biotech/pharma development preferred. • Tech Writing experience in biotech/pharma preferred. • Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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: $38.00/hr.
