Quality - Technical writer

Quality - Technical Writer
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
View email address on click.appcast.io
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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.