Technical Writer and Document Analyst

Job DescriptionThe 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 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, Manufacturing Sciences and Technology, Operations, Quality and Regulatory Sciences. 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 delivery of approved technical documents in accordance with 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, revise draft sections as needed to ensure content clarity and consistency across 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, review and data verification of clinical regulatory submissions.Work independently under supervision and collaborates with other teams.Work effectively in cross-functional project teams to accomplish company goals.Represent clinical technical writing on cross-functional CMC teamsSupport and implement continuous process improvement ideas and initiativesMentor and train employees on the technical writing processesAssist with dossier creation and system complianceQualificationsBachelor'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 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 regulatory documentum software (CARA, eSub, etc) is strongly preferred along with proficiency in compliance ready standards for final publication.Experience in bio tech/pharma development required, cell therapy experience preferred.Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.BenefitsHealthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.Synectics is an equal opportunity employer.