Project RA Submission Management Associate II

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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

Kite is seeking a highly motivated individual to join us as an Associate II Project Management to work in the exciting area of cancer immunotherapy. This position will provide project management and regulatory filing support to the global Regulatory CMC team in a dynamic and fast paced organization. The preferred candidate will possess strong interpersonal skills as this position interacts with all levels of employees in Technical Operations (Process Development Quality Supply Chain Manufacturing) and Regulatory Affairs across multiple geographies.
Are you interested in helping ensure timely execution of CMC strategy in a cell therapy setting Come join us in our mission to cure cancer!

RESPONSIBILITIES:

• Drive cross-functional submission project teams and manage regulatory submission deliverables; may partner with a more senior project manager on larger projects.

• Develop and maintain submission timelines (e.g. Gantt charts) risk management strategies and risk/issue logs meeting minutes decision and action item logs and other project management tools.

• Partner with Regulatory CMC and Technical Operations to ensure the coordinated preparation and completion of regulatory documents for submissions and requests for information.

• Manage regulatory submission documents including file organization transfer between systems and traceability from draft through approval and publishing.

• Foster productive communication and alignment across Regulatory Affairs functionsincluding Regulatory CMC Regional Regulatory Leads Labelling Regulatory Operations and other relevant stakeholderswhile ensuring effective coordination between Regulatory CMC and Technical Operations through proactive facilitation networking and timely updates on progress and issues (e.g. project dashboards and reporting).

• Support the optimization and deployment of business processes and tools to improve efficiency and advance collaboration.

REQUIREMENTS:

• BA/BS degree with 4 years of experience in Life Sciences Biotechnology Pharmacy or related technical field.

• MA/MS or MBA with 2 years of aforementioned experience

ADDITIONAL QULAIFICATIONS and INFORMATION:

• Experience managing multiple projects simultaneously with strong organizational skills and attention to detail

• Knowledge of the drug development process cell therapy industry and Regulatory CMC practices; Module 3 experience strongly preferred

• Demonstrate the ability to take the initiative to think critically and troubleshoot problems

• Excellent interpersonal verbal and written communication skills are essential in this collaborative work environment

• Ability to interact with staff at all levels in a fast-paced environment remaining flexible resourceful and efficient with a high level of professionalism and confidentiality

• Proficient in MS Word Excel Power Point Outlook Teams SharePoint; Smartsheet and other project/productivity tools experience a plus

• Experience in Veeva Vault platform and AI tools.

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.