Intern - PDM - CMC Regulatory

Gilead Sciences•Foster City, CA

5d•$19 - $55•Onsite

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. 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 Gilead and help create possible, together. Job Description As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company’s mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. A summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus of Gilead Sciences. The candidate should be enrolled in an Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs or closely related subject. The summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed applications in line with regulatory requirements, company policies and procedures.

Requirements

Must be at least 18 years old
Must have a minimum GPA of 2.8
Authorized to work in the United States without Sponsorship now or in the future or CPT/OPT through your University.
Must be currently enrolled as a full-time student in a Bachelor’s/Masters/MBA/PhD program at an accredited US based university or college
Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student
Must be enrolled full-time in the Fall Semester at an accredited university/college after the completion of the internship
Must be able to complete a 10-12 consecutive week internship between May and August
Must be able to relocate if necessary and work at the designated site for the duration of the internship

Nice To Haves

Preferred Degree qualification: Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs or closely related subject
Proficiency with MS Office Suite
Ability to identify issues and seek solutions
Ability to work both independently and collaboratively
Demonstrated commitment to inclusion and diversity in the workplace
Efficient, organized, and able to handle short timelines in a fast-paced environment

Responsibilities

Under general supervision and guidance of the CMC RA Foster City team, develop required regulatory skills and knowledge for assisting in the preparation of regulatory submission documents including notifications, supplements and annual reports to clinical trial applications and marketing authorizations for assigned territories, as applicable
May contribute to local process improvements with potential impact to the CMC RA department, including but not limited to information in our regulatory and change control systems
Work cross-functionally within a matrixed organization
Showcase your work with a final presentation near the conclusion of your internship
Showcase your work with a final presentation (PPT) near the conclusion of your internship