2023 Summer Intern – Product Development Regulatory Documentation
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 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 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.
This internship position is located in on site, in South San Francisco.
Key Responsibilities
Job duties to be assigned by the supervisor. 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 arean (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.
Program Highlights
- Intensive 6 months, full-time (40 hours per week) paid internship
- Program start dates are in May/June 2023
- Ownership of challenging and impactful business-critical projects
- Work with some of the most talented people in the biotechnology industry
- Final presentations of project work to senior leaders
- Lead or participate in intern committees to design and coordinate program events and initiatives
- Professional & personal development curriculum throughout the program, including networking opportunities, workshops, and panel discussions
- Participate in volunteer projects, social events, and team-building activities
Who You Are
Education:
- Any Degree Level. Undergraduates who have completed at least one year of undergraduate coursework at a university, current graduate students (MS or PhD) who are available to work full time for the duration of the internship, or recent grads (within 2 years of receiving their last degree).
- 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.
Preferred majors: any medicine/biology-related majors, english, bioengineering, biotechnology, regulatory
- Candidates may be PharmD or PhD graduates, but those degrees are not required.
Other Qualifications
- Excellent communication, collaboration, and interpersonal skills
- Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion
- 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
Along with the submission of your CV, a cover letter is optional.
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location for this position of California is $21.00 – $50.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits.