Senior Manager, Research Technical Writer (Project Management)

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.

Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a highly motivated individual with solid scientific background and technical writing experience to join us as Senior Manager, Research Technical Writer (Project Management), reporting to the head of Research Operations. The successful candidate will serve as the lead writer in Research and Translational Medicine for non-clinical and clinical reports, required for regulatory filings (e.g. IND, BLA and amendments etc.). Additionally, the Senior Manager, Research Technical Writer will manage and executive the end to end process of delivering these documents. Other responsibilities include updating SOPs as needed, providing training of regulated document process within Research, and act as the lead lesion for electronic lab notebook (ELN) compliance.

The Senior Manager, Research Technical Writer will work closely with key cross-functional stakeholders from Research, Research Project Managers, Program Managers, Regulatory Affairs, Regulatory writers, Documentation Management, and Legal within Kite and Gilead.

Key Responsibilities include, but at not limited to

• Write, edit, review and manage the internal report development process to deliver research non-clinical technical reports for INDs, BLAs, MAAs, and associated regulatory submissions.
• Collaborate closely with Research Teams and Translational Medicine to ensure production of consistent, accurate, high-quality technical reports meeting regulatory requirements.
• Perform literature searches as needed and summarize data for incorporation into documents.
• Adhere to company Style Guide, templates, and SOPs for document development.
• Streamline, maintain and execute the end to end process for coordination of authoring, editing, reviewing, verifying and approving regulated Research technical reports.
• Create and maintain report template and data dictionaries for all Research reports.
• Partner closely with Research scientists, Program Mangers, Research Project Manager, Regulatory Writers, Regulatory Affairs, and Documentation Management to align on timelines and deliverables.
• Responsible for tracking all report deliverables for programs in scope; follow up with reviewers and approver as needed to ensure timely delivery.
• Provide training to Research staff on the process of regulated technical reports as needed.
• Maintain department ELN business process and liaise with legal and lab managers to ensure compliance of the requirements.
• Represents Research during upgrades and changes to the regulatory document management system; provides training on relevant changes to Research staff.
• Write, revise and edit departmental SOPs as needed.

Key Requirements:

• 8+ years of relevant experience and a BS in science or; 6+ years of relevant experience and a MS or MBA; 2+ years of relevant experience and a PhD in a scientific field or a PharmD, DVM or MD degree.
• Strong scientific background in cellular immunology, oncology, or related discipline is a plus.
• Previous experience with regulatory writing or research non-clinical study reports, clinical study reports focusing on translational medicine, and SOPs preferred; other relevant experience considered.
• Demonstrated advanced writing skills with strong command of English language and grammar.
• Must possess excellent interpersonal, written and verbal communication skills along with ability to work collaboratively in a team environment.
• Efficient, organized, and able to handle short timelines in a fast-paced environment
• Must be able to prioritize workload, and support multiple deliverables simultaneously.
• Efficient, organized, and able to handle short timelines in a fast-paced, dynamic environment.
• Proficient with document management software/systems, such as filing systems and ELN.

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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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