Quality - Technical writer

Primary Responsibilities

• Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical, commercial, and life-cycle CMC regulatory submissions and responses to health authority questions based on high-quality technical reports.
• Partner with SMEs across CTDO to identify source documents, and align delivery of approved technical documents in accordance with project timelines and aligned with CTD requirements and regulatory strategy.
• Provide input and scientific oversight for content generation for modules 2.3 and 3.
• Review and adjudicate comments, facilitate comment resolution, and revise draft sections.
• Ensures content clarity/ consistency in messaging across dossier.
• Represent Tech Writing and document management in cross-functional CMC teams.
• Manage the logistical process and detailed timeline for scientific and regulatory content creation for clinical, commercial, and life-cycle CMC regulatory submissions and responses to health authority questions.
• Aid with dossier creation and system compliance for regulatory submissions.
• Coordinate with CMC matrix team leaders to ensure timely submissions.
• Support and implement continuous process improvement ideas and initiatives.
• Mentor and train employees on the technical writing processes.
• Collaborate with cross-functional team for effective logistical process and detailed timeline for scientific/ regulatory content creation for clinical, commercial, and life-cycle CMC regulatory submissions and responses to health authority questions.
• Aid with dossier creation and system compliance for regulatory submissions.

Competencies & Experiences

• Bachelor's degree or equivalent in relevant discipline with a minimum of 2 years' experience (4-7 years for senior level).
• 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 regulatory Documentum software (CARA, eSub, etc.) is strongly preferred, along with proficiency in compliance-ready standards for final publication.
• Experience in biotech/pharma e2e product development required.
• Must be capable of working in a fast-paced, changing team environment, prioritizing multiple tasks to meet filing deadlines.
• Adds Job Responsibilities for 2nd Technical Writer Position - Pipeline assets - Technical Writer responsibilities:
• Plan and manage logistics of regulatory submissions and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets.
• Set up submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to maintain tracker.
• Track upcoming submissions and ongoing submission progress.
• Co-author/ author scientific content for CTD Quality sections in regulatory submissions across all pipeline assets.
• Review submission content and run comment resolution meetings for submissions.
• Ensure formatting and messaging are consistent across different sections of dossier.
• Coordinate response authoring, review, and data verification to queries from HA for submissions.
• Interact and facilitate submission-related meetings with CMOs.
• Represent TW&DM in cross-functional team meetings.