Sr Manager, Regulatory Writing

The Senior Manager, Regulatory Writing will serve as the lead writer for assigned programs and will be responsible for writing and delivery of clinical documents for INDs, BLAs, MAAs, and associated regulatory submissions. You will supervise contract and in-house writers. On-site preferred.
Roles and Responsibilities:

• Serve as medical writing lead for regulatory documents related to clinical trial programs
• Write/edit/review content of clinical trial-associated documents for new and ongoing programs
• Lead document preparation for major filings (eg, BLAs), including development and management of document timelines and resource planning
• 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 company Style Guide, templates, and SOPs for document development
• Collaborate with and supervise contributions from contractors and vendors
• Commit to company timelines for all assigned documents

Requirements:

• Advanced degree in life sciences preferred; other relevant experience considered
• 5 years of industry experience in regulatory writing
• Experience with clinical trial protocols, investigator's brochures, clinical study reports, safety narratives, CTD clinical summaries; experience with biomarker reports preferred
• Knowledgeable of US and international regulations
• Strong scientific background in cellular immunology, oncology, or related discipline is a plus
• Demonstrated writing skills with strong command of English language and grammar
• Proficiency with MS Office Suite, EndNote, and MS Word templates
• Strong oral and written communication skills
• Efficient, organized, and able to handle short timelines in a fast-paced, dynamic environment
• Ability to work both independently and collaboratively
• Ability to evaluate issues, ask questions, and propose solutions
• Prior supervisory experience preferred

Kite is a biopharmaceutical company 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. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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