Intern - Regulatory Affairs - Regulatory Policy and Intelligence at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

InternshipExperience Level

InternshipJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

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

Responsibilities

Conduct research on novel and innovative oncology approaches, including topics such as the contribution of components in PD-L1 combination strategies, validation methods for novel endpoints, and biomarker investigations (75%)
Draft science-based articles intended for review, consideration, and presentation to regulatory agencies
Assess the impact of regulatory guidelines from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or the International Council for Harmonization (ICH) on Gilead’s oncology portfolio (25%)
Perform both quantitative and qualitative analyses to support findings
Engage in cross-functional collaboration with Development, International Regulatory Affairs, and other stakeholders to understand research priorities
Conduct background research on FDA, EMA, and ICH guidelines, or other relevant data to support Gilead’s non–cell therapy oncology pipeline
Identify areas where regulatory guidance may lack clarity, be outdated, or where new references are anticipated
Contribute to the development of research methodologies and project plans
Compile and analyze qualitative and quantitative data
Present findings in a professionally formatted deliverable to the broader team
Potentially submit the project as an article to professional societies, journals, or conferences
Showcase your work with a final presentation (PPT) near the conclusion of your internship

Skills

Regulatory Affairs

Regulatory Policy

Oncology Products

Policy Research

PD-L1

Biomarkers

Scientific Writing

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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