Technical writer Job at LOGIXtech Solutions in New Brunswick

Overview

Our client, a leading pharmaceutical company, is hiring a Technical Writer on a contract basis.

Job ID: 83415

Work Location: New Brunswick, NJ – 50% on site

Education/Experience

• Required Bachelors degree in Biology or related discipline with 2 years’ experience
• 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.

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 across CTD pipeline assets.
• 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.
• Ensures 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 CTD 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.

Pay: $43-$44/hr