South San Francisco, California
Start Date: Summer 2021
Work Hours: 40 hours per week
Given the current uncertainty of the global pandemic and work from home situation for 2021, this internship is currently planned to be virtual with the option for interns to work remotely from within the U.S. Borders. We will keep candidates informed if this changes.
Due to the ever changing situation concerning the COVID-19 global pandemic, for our summer 2021 internship program we will only consider international candidates who are currently in the US and will remain in the US for the duration of the internship.
Product Development Regulatory (PDR) is responsible for maintaining product license applications and for the timely submission of such applications to Health Authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. This intern position is in the Regulatory Affairs department, involving global product development and post-marketing programs, working with key partners across development. Additional activities may involve supporting, as necessary, global and US product labeling, US promotion and advertising, working with key partners in Production, Quality, Marketing, Legal, and Development (The intern will be assigned to one of the departments within PDR that may involve these activities). The successful candidate will participate directly with one or more of our current molecule teams. This is an opportunity to explore applying your science background in a business environment for the development of new medicine. The internships are 3-6 months in duration with a maximum internship duration cap of 12 months.
Please note that this job posting is to express your interest in a future internship position within the PDR group. There may not be an open internship opportunity at the time that you apply.
QUALIFICATIONS & EXPERIENCE:
The successful candidate will be working towards or have recently (within the last two years) completed an undergraduate degree, preferably in the biological sciences. Candidates may have recently completed a graduate degree (within 2 years of graduation) or be currently enrolled in a graduate program with the ability to take a 6 month to 1-year break to work full time on the internship. Candidates may be PharmD or PhD graduates, but those degrees are not required.
Some skills and qualifications a candidate will need to thrive in an internship within PDR are:
Understand the needs of the project and proactively drive them
Adapt and respond to changes in a positive and thoughtful manner
Be comfortable with uncertainty and support a team through challenges
Able to balance multiple priorities and organize their time effectively
Identify and solve problems and, if needed, escalate issues appropriately
Use of interpersonal skills and influence to accomplish work without formal authority
JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:
Job duties to be assigned by the supervisor. Depending on availability, interns will be given an internship in one of the following departments (Internship projects in PDR will be in one of the following areas).
Labeling: Leads the development of product labeling for the company Core Data Sheet, US Prescribing Information (USPI), and EU Summary of Product Characteristics (EU SmPC) for products across all therapeutic areas.
Regulatory Intelligence: Researches and interprets the needs of health authorities and provides information necessary to project teams in different development stages to aid in strategic regulatory decisions. Works with all program teams across all therapeutic areas.
Program Management (PDR-PM): This role is in the Oncology or I2ONE (Immunology, Infectious Disease, Ophthalmology, Neuroscience, and Established Products) parts of PDR. Develops and implements innovative regulatory strategies from pre-clinical through to Phase 4 molecules, including direct interactions with the FDA.
Regulatory Documentation (PDRD): Works closely with cross-functional teams to prepare regulatory documents for submission to regulatory authorities within subject area (clinical/safety).
Regulatory Operations (PDRO): A centralized community of individuals with specialized skills and knowledge 'deployed' to meet PDR priority needs.
Regulatory Business Office (RBO): The RBO’s purpose is to help our customers from strategy to outcomes, partnering to make it happen. We bring value to our customers in areas such as Strategy, People, Delivery, and Process & Data, working across all functions in PDR and in partnership with PD.
Regulatory Disclosures and Data Sharing: Regulatory Disclosures manages the accurate and timely posting of company trial protocols and study results on global registries managed by Health Authorities. In addition, Disclosures shares global clinical study documents with Health authorities as well as any internal or external requesters.
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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