Job Description
Quality - Technical Writer
Job Number: 26-00813
Job Number: 26-00813
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Quality - Technical Writer for our client in New Brunswick, NJ.
ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- 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.
- Work effectively in cross-functional project teams to accomplish company goals.
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.
Required Qualifications:
- 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 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 and GPS organization.
Pay Rate: $42.85-$45.45/Hour
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 interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | LinkedIn
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.
Numbers & Facts
| Location | New Brunswick, NJ |
| Industry | Staffing/Employment Agencies |
| Salary | $42.85–$45.45 Per Hour |
| Company Size | 500 to 999 employees |
| Year Founded | 1999 |
| Website | http://www.eclaroit.com |
About Company
Eclaro is a Business and Technology Consulting Firm that connects top talent with opportunities nationwide. We have direct access to Hiring Managers from leading Fortune 1000 organizations in almost every industry segment, with particular expertise in:
• Technology and Business Consulting
• Financial Services and Insurance
• Pharmaceuticals and Life Sciences
• Consumer Products, Public Sector, and Utilities
Eclaro provides fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including:
• Consulting
• Professional Hiring
• Global Integrated Delivery™
• Managed Services
Eclaro recruits and manages a staff of highly skilled individuals in an array of specialized disciplines enabling our clients to leverage new opportunities, respond to increased and changing demands, and increase their profitability.
Eclaro’s Management Team averages over 25 years of experience in partnering with clients in technical, corporate operations and human capital solutions. We hold ISO 9001:2008 certification and have achieved SOC 2 Type 2 certification in Security, Availability and Confidentiality. Eclaro’s decades of expertise and collaborative practice have proven that The Right People are The Answer.
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Skills
- Adjudicationunmatched
- Analytical Developmentunmatched
- Best Practicesunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Clinical Practices/Protocolsunmatched
- Communication Skillsunmatched
- Computer Skillsunmatched
- Cross-Functionalunmatched
- Data Managementunmatched
- Dental Insuranceunmatched
- Detail Orientedunmatched
- Diversityunmatched
- Document Managementunmatched
- Documentationunmatched
- GPS (Global Positioning System)unmatched
- Geneticsunmatched
- Healthcareunmatched
- Logistics Managementunmatched
- Logistics Processesunmatched
- Medical Productsunmatched
- Mentoringunmatched
- Microsoft Excelunmatched
- Microsoft Officeunmatched
- Microsoft SharePointunmatched
- Microsoft Wordunmatched
- Negotiation Skillsunmatched
- Organizational Skillsunmatched
- Presentation/Verbal Skillsunmatched
- Process Developmentunmatched
- Process Improvementunmatched
- Process Managementunmatched
- Product Developmentunmatched
- Project Portfolio Management (PPM)unmatched
- Project/Program Managementunmatched
- Publicationsunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Regulatory Submissionsunmatched
- Staff Trainingunmatched
- Team Lead/Managerunmatched
- Technical Deliveryunmatched
- Technical Operationsunmatched
- Technical Writingunmatched
- Time Managementunmatched
- Vision Planunmatched
- Writing Skillsunmatched
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