Senior Manager, Regulatory Writing
Regulatory Affairs | Santa Monica, CA | Full Time
Kite, A Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term, durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. For more information on Kite, please visit www.kitepharma.com.
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
- Doctorate in life sciences preferred; other relevant experience considered
- 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 strong command of English language and grammar
- Proficiency with MS Office Suite, Endnote, and MSWord templates
- Strong oral and written communication skills
- 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
Kite, A Gilead Company is an equal opportunity employer based in beautiful Santa Monica, CA. Kite offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment.
To learn more about us, please visit our website at www.kitepharma.com.
No phone calls please and no agencies or recruiters.