Job Information
Gilead Sciences, Inc. Project / RA Submission Management Associate II in Hoofddorp, Netherlands
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
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 functions—including Regulatory CMC, Regional Regulatory Leads, Labelling, Regulatory Operations, and other relevant stakeholders—while 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 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 .
Equal 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 individual’s 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.
Change The World With Us
Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.
While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.