The Senior Manager, Regulatory Writing will report to the Director of Regulatory Writing. The regulatory writer will be responsible for writing and/or editing clinical documents for INDs, BLAs, MAAs, and associated regulatory submissions.

Roles and Responsibilities (including, but not limited to):

• Serve as medical writing lead for clinical trial-related regulatory documents
• Write/edit/review content of clinical trial-associated documents for new and ongoing programs
• Work with cross-functional teams to ensure production of high-quality written documents
• Perform literature searches as needed, and summarize data for incorporation into documents
• Adhere to Kite Style Guide, templates, and SOPs for document development
• Perform QC checks on document content
• Commit to company timelines for all assigned documents
• Manage/coordinate contributions from contract writers

Requirements:

• MS/MA +6 years regulatory writing or relevant experience required
• Ph.D. preferred with 3-5 years' experience in regulatory writing or equivalent experience
• Experience with clinical trial protocols, investigator's brochures, clinical study reports, safety narratives, other safety reports, or CTD clinical summaries
• Knowledgeable of US and international regulations
• Strong scientific background in cellular immunology or related field, or oncology, is a plus
• Demonstrated advanced writing skills, with a strong command of English language and grammar
• Proficiency in MS Office Suite, Endnote, and MSWord templates
• Strong oral and written communication skills
• High attention to detail
• Efficient, organized, and able to handle short timelines in a fast-paced environment
• Ability to work both independently and collaboratively
• Ability to identify issues and propose solutions

NOTE: This position can remote.