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Biotechnology, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
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.
The Senior Manager, Regulatory Promotions position will report to the Vice President of Regulatory Affairs and will serve as the primary point of contact for the review and approval process of materials used to communicate about the company and its products.
Roles and Responsibilities (include but are not limited to):
Ensure that projects are completed on schedule following established procedures and timelines
Develops solutions to complex problems, which require a high degree of ingenuity, creativity, and innovation
Schedule and facilitate meetings serving as the single point of contact for meeting coordination
Ensure consistency across functions for coordination of submissions, categorizing review types and prioritizing materials for review
Document required changes and comments during materials review meetings and communicate final approvals
Ensure active materials are reviewed annually
Participate in implementation of relevant software systems related to Materials Review and perform User Acceptance Testing
Train materials sponsors, reviewers and outside vendors on the process and system
Supports strategic planning, development, workflow modifications, and updating operations guidelines and SOP's
Monitor daily operations and adherence to SOP's
Track and report performance metrics
Other duties as assigned
Bachelor's degree in business or biological sciences
5+ years biotech or pharmaceutical industry experience required
Demonstrated excellence in project management and effectively managing multiple projects/priorities
Strong, open and transparent communication skills (verbal and written)
Strong computer skills - experience with : MS Office and document management systems
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
Willingness to think outside of the box and adapt best practices to our small, but growing environment
Ability to adapt in a constantly evolving environment
Self-motivated with a strong sense of ownership in areas of responsibility
High degree of professionalism, ethics and integrity
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of the first 500 employees in this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
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 b...ased 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.