Intern Research amp Development

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Job Description COMPANY SUMMARY:At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist marketed under the brand name \Ocaliva u00ae \ in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva u00ae was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016. Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2022.People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.At Intercept, we foster an environment that celebrates creativity, collaboration, and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.POSITION SUMMARY:As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking an Intern, Research & Development.The Intercept Research & Development (R&D) department seeks a highly motivated, team-oriented, and flexible individual to work within an exciting and dynamic environment.The R&D Intern will support a department within Intercept's R&D function, introducing students to the roles of clinical operations, program management, clinical development and regulatory affairs in the pharmaceutical industry. The program is designed to:nnprovide students with experience on how to project manage planned and ongoing research initiativesngain insight into the complex nature of how a growing biotech company works, including the regulatory environment in which the pharmaceutical industry operates.nnThis is a 3-month, paid summer internship (approximate program dates: May 23, 2022- August 26, 2022).CORE ACCOUNTABILITIES:Key Learning Objectives during the internship will include the following:nnProvide support in project-specific tasks related to the overall management of clinical trialsnConduct regulatory intelligence research and analysis to support planning and implementation of drug development activitiesnMaintain clinical and regulatory tracking documents and spreadsheetsnAssist in coordinating materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetingsnGain an understanding of external stakeholders in pharmaceutical industry (i.e., healthcare practitioners, payers, patients, and policy-makers)nGain exposure to FDA guidelines/regulations and industry compliancenAs needed, assist with general day-to-day R&D activitiesnUnderstand the legal and compliance environment and drive collaboration with the Legal and Compliance teamnDrive the spirit of \ONE Team\ across all functions by supporting a team approach to focus on our patients and customers as our top prioritiesnMake Intercept a truly desired place to worknnExperience and Skills QUALIFICATIONS:nnUndergraduate rising junior or senior, pursuing a STEM, life sciences or healthcare degree.nThe ability to work 30 - 40 hours per week (minimum of 30 hours) for approximately 12-14 weeks.nThe ability to work remotely (currently), with the flexibility of commuting/occasional travel to Morristown, NJ or San Diego, CA office, if/when in-person meetings occur.nnREQUIRED KNOWLEDGE AND ABILITIES:nnPresentation to cross-functional colleagues at the end of the session (mandatory) Ability to complete the entire 3-month session (time off should be arranged prior to program start with Hiring Manager)nCumulative 3.0 GPA or above; college transcript requirednCurrently enrolled in an accredited college/universitynModerate scientific and/or healthcare-related knowledge and skills to support the tasks and projects of this rolenStrong multitasking and project support skills; ability to stay organized and work through a project from start to finishnStrong ability to be flexible and work collaboratively in an engaging work environmentnStrong verbal and written communications skillsnLearning agility and 'scalability' to take on increasing responsibility as projects/needs allownConsistent demonstration and embodiment of company core values: Come Together, Be Yourself, Own the Solution, Embrace the Challenge, Keep Exploring.nAbility to have fun and thrive in a growing, diverse, and inclusive work environmentnn}

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