Offer summary

Qualifications:

Bachelor's degree in a relevant field; advanced degree preferred., Experience in regulatory affairs, particularly with FDA submissions., Strong project management skills and ability to coordinate cross-functional teams., Excellent communication and documentation skills..

Key responsabilities:

Manage the end-to-end Promotional Review Committee (PRC) process.

Coordinate PRC meetings and serve as the main point of contact.

Ensure compliance and quality of promotional material submissions to the FDA.

Monitor daily operations and adherence to standard operating procedures (SOPs).

Job description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

The Regulatory Affairs, Advertising and Promotion (RA Ad Promo) group seeks a Manager at Kite, a Gilead Company, in Santa Monica, CA. The Manager is responsible for managing the internal Promotional Review Committee (PRC) process and the submission of promotional materials for marketed prescription drug or biologic products to the US Food and Drug Administration (FDA). The RA Ad Promo group provides commercial regulatory strategy and leadership at Gilead and Kite to enable the business support patients and meet its commercial needs in a compliant manner.

Responsibilities

Manage the Promotional Review Committee (PRC) process end-to-end and act as a project manager for the PRC, Marketing, and other cross-functional stakeholders in order to ensure accurate, timely, and compliant review of materials
Schedule PRC meetings serving as the point of contact for meeting coordination
Facilitate and document required changes and comments as part of PRC during meetings
Manage product label updates and collaborate with cross-functional stakeholders to ensure materials are revised, resubmitted for PRC Review, and submitted to FDA on form 2253
Ensure consistency and quality of PRC submissions
Maintain the promotional material library to ensure active/approved materials are re-reviewed per internal guidelines
Monitor daily operations and adherence to SOP(s)
Create and manage timely submissions of promotional materials to the FDA (i.e. FDA 2253, Request for Advisory Comments)
Ensure that projects are completed on schedule following established procedures and timelines as it relates to the PRC process and submissions to the FDA
Participate in ongoing PRC Operational projects to enhance efficiencies in Kite PRC processes
May represent group in cross-functional and Regulatory Affairs working groups and present project status updates to group
Maintain Kite US Reference Library standards and associated Claims

The salary range for this position is: $133,195.00 - $172,370.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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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