Intern Regulatory Affairs, Oncology

1 month ago


Foster City, United States Gilead Sciences, Inc. Full time
Intern Regulatory Affairs, Oncology
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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.

Key Responsibilities will include, but are not limited to the following:
Interns will assist the Global Regulatory Affairs Oncology Liaison team with projects to support department goals and objectives.Interns will assist with development and submission of regulatory documents such as clinical study reports, study protocols and protocol amendments, and assist with activities in preparation for annual reporting requirements (e.g., Investigator Brochure, Orphan Annual report, etc.).In addition, the intern work across the global regulatory network on various research projects and present their findings at team meeting and a final poster board presentation at the conclusion of their internship

Required Qualifications:
Must be at least 18 years oldMust have a minimum GPA of 2.8Authorized 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 collegeMust be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral StudentMust be enrolled full-time in the Fall Semester at an accredited university/college after the completion of the internshipMust be able to complete a 10-12 consecutive week internship between May and AugustMust be able to relocate if necessary and work at the designated site for the duration of the internship

Preferred Qualifications:
Preferred Degree qualification: PharmDProficiency with MS Office SuiteAbility to identify issues and seek solutionsAbility to work both independently and collaborativelyDemonstrated commitment to inclusion and diversity in the workplaceEfficient, organized, and able to handle short timelines in a fast-paced environment

Gilead Core Values:
Integrity (Doing What's Right)Inclusion (Encouraging Diversity)Teamwork (Working Together)Excellence (Being Your Best)Accountability (Taking Personal Responsibility)

The expected hourly range for this position is $19.00 - $55.00.

Gilead considers a variety of factors when determining base compensation, including education level and geographic location. These considerations mean actual compensation will vary.

Benefits include paid company holidays, sick time, and housing stipends for eligible employees.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

jeid-c6648ee342e3d046a4c4eaac1efd2a10


  • Foster City, United States Integrated Resources, Inc ( IRI ) Full time

    Job Title- Senior Manager, CMC Regulatory Affairs, BiologicsJob Duration: 6 MonthsJob Location: Foster City,CA RESPONSIBILITIES MAY INCLUDE• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products....


  • Foster City, California, United States Integrated Resources, Inc ( IRI ) Full time

    Job Title: Senior Manager, CMC Regulatory Affairs, BiologicsJob Duration: 6 MonthsJob Location: Foster City, CAResponsibilities:Prepare Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency questions for biologics products.Interact with departments outside of CMC Regulatory...


  • Foster City, California, United States ATR International Full time

    Regulatory Affairs Assistant - IIWe are seeking a highly skilled Regulatory Affairs Assistant - II to join our team at ATR International. This role is a great opportunity for someone who is passionate about advancing therapeutics against life-threatening diseases, while working with a collaborative team in Regulatory Affairs.Key Responsibilities:Perform data...


  • Foster City, United States Gilead Sciences, Inc. Full time

    Intern CMC Regulatory Affairs - BiologicsUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with...


  • Foster City, California, United States ATR International Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Manager III to join our team at ATR International. This role will be responsible for leading the preparation of quality sections of regulatory submissions, including INDs/IMPDs, new marketing authorization applications, and post-approval variations.Key Responsibilities:Prepare high-quality...


  • Foster City, California, United States Net2Source Inc. Full time

    Job Title: CMC Regulatory Affairs ManagerNet2Source Inc. is seeking a highly skilled CMC Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for our biologics products.Key Responsibilities:Prepare and submit high-quality CMC regulatory...


  • Foster City, California, United States Gilead Sciences Full time

    {"Responsibilities": "As a Senior Manager, Regulatory Affairs III at Gilead Sciences, you will be responsible for preparing high-quality regulatory submissions for biologics products. This includes preparing the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency questions. You...


  • Redwood City, California, United States Revolution Medicines Full time

    Revolution Medicines: A Leader in Precision OncologyWe are seeking an experienced Associate Director of Regulatory Affairs to join our team at Revolution Medicines, a clinical-stage precision oncology company dedicated to developing novel targeted therapies for RAS-addicted cancers.The OpportunityAs a key member of our Regulatory Affairs team, you will...


  • Foster City, California, United States ATR International Full time

    Job SummaryWe are seeking a highly skilled Senior Manager, Regulatory Affairs III to join our team at ATR International. This role will be responsible for leading the preparation of Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency questions for a range of biologics...


  • Foster City, United States ATR International Full time

    Job DescriptionJob DescriptionWe are seeking a Senior Manager, Regulatory Affairs III for a very important client. RESPONSIBILITIES MAY INCLUDE• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics...


  • Foster City, California, United States ATR International Full time

    Job OverviewWe are seeking a highly skilled Senior Manager, Regulatory Affairs III to join our team at ATR International. This role will be responsible for leading the preparation of Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency questions for a range of biologics...


  • Foster City, California, United States ATR International Full time

    Job Title: Senior Manager, Regulatory Affairs IIIWe are seeking a highly skilled Senior Manager, Regulatory Affairs III to join our team at ATR International.Key Responsibilities:Prepare high-quality CMC sections for INDs/IMPDs, marketing authorization applications, post-approval variations, renewals, and responses to agency questions.Collaborate with...


  • Foster City, California, United States Mindlance Full time

    Job Title: Senior Manager, CMC Regulatory Affairs, BiologicsAs a key member of the Mindlance team, you will be responsible for preparing high-quality regulatory submissions for biologics products. This includes preparing the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency...


  • Foster City, United States ATR International Full time

    RESPONSIBILITIES MAY INCLUDE• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans....


  • Foster City, United States ATR International Full time

    RESPONSIBILITIES MAY INCLUDE• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans....


  • Foster City, United States Gilead Sciences Full time

    RESPONSIBILITIES MAY INCLUDE• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans....


  • Foster City, California, United States Fladger Associates Full time

    Job Title: CMC Regulatory Affairs Data Entry SpecialistFladger Associates is seeking a highly skilled Regulatory Affairs Data Entry Specialist to join our team in Foster City, CA. As a key member of our Regulatory Affairs team, you will be responsible for performing data entry using our Company RIM System to support key CMC RA stakeholders.Key...


  • Foster City, California, United States Innova Solutions Full time

    Job DescriptionInnova Solutions is seeking a highly skilled Regulatory Affairs Assistant - II to join our team. As a key member of our Regulatory Affairs team, you will be responsible for performing data entry using our Client RIM System to support key CMC RA stakeholders.Key Responsibilities:Perform data entry using Client RIM System to enter relevant...


  • Foster City, United States Net2Source Inc. Full time

    Position: Senior Manager, Regulatory Affairs III*Location: Foster city, CADuration: 06+ Months (Extendable) Projected for 06 months and beyond depending on the business need.This Position is REMOTE Pay Rate: $85-100.00/hr on W2 Paid weekly (Without Benefits included in the pay you will have you buy them separately by paying price for the benefits)Client: Bio...


  • Foster City, United States Net2Source Inc. Full time

    Position: Senior Manager, Regulatory Affairs III*Location: Foster city, CADuration: 06+ Months (Extendable) Projected for 06 months and beyond depending on the business need.This Position is HYBRID Pay Rate: $85-100.00/hr on W2 Paid weekly (Without Benefits included in the pay you will have you buy them separately by paying price for the benefits)Client:...