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Intern- Research and Early Development- ECD Quality and Compliance Operations (6-months)

Posted on: January 27, 2021 Apply Now
NW Internship Expires April 27, 2021

Intern- Research and Early Development- ECD Quality and Compliance Operations (6-months)

South San Francisco, California

Job ID: 202101-101341 (http://jobs.gene.com/202101-101341)

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(https://www.gene.com/careers/find-a-job) The Position

Start Date: Summer 2021

Work Hours: 40 hours per week

Length of Assignment: 6 months, possibility to extend.

Education Level: Bachelor’s, Master’s, PhD (pursuing PhD, not completed), PharmD, MBA ( must be able to commit to a 6-month long full-time position, so applicants should not be currently enrolled in school)

Preferred Majors/Disciplines: Science or Healthcare discipline of study preferred.

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.

Quality Compliance Operations (QCO) was launched in September 2013, forming the backbone of quality oversight and management in Early Clinical Development (ECD) for Genentech Research & Early Development (gRED).

The mission of the QCO group is to enable a proactive compliance approach in ensuring alignment and successful delivery of enterprise wide quality and compliance programs. As a trusted strategic partner, we engage, educate and empower gRED to effectively execute quality and compliance risk-based solutions.

Job Description/Responsibilities

Within this intern role, you will be supporting the QCO within gRED ECD. The QCO serves as the backbone of quality oversight and management in ECD. The QCO enables a proactive compliance approach in ensuring alignment and successful delivery of enterprise wide quality and compliance programs.

You will gain hands-on experience in the day-to-day activities within the Quality & Compliance Office, while also obtaining a high-level understanding of the execution of clinical trials needed to bring novel drugs to patients. You will be given specific tasks to support teams and functional roles within the department. You will also have an opportunity to shadow and follow individuals from the department. Some positions you may have the opportunity to shadow include: Quality & Compliance Specialist, Sr./Principal Quality & Compliance Manager, and Clinical Compliance Lead.

You may be required to do the following:

  • Research and summarize topics for and to the broader group. Topics may include industry trends specific to clinical development (Healthcare compliance, privacy, artificial intelligence, FDA guidance, enforcement of regulations, etc.)

  • Interview and interact with internal and external stakeholders to obtain input on various assigned projects

  • Participate in the delivery of a process or technical solution to support the QCO or ECD

  • Create and track metrics

  • Contribute to project plans, establishing timelines and deliverables, assessment of critical dependencies across projects, developing meeting agendas/minutes, tracking and driving completion of action items

  • Prioritize workloads and ensure deadlines are met

  • Help review study or department related documents and liaise with accountable members to address inconsistencies and missing information

  • Develop a poster for Genentech Intern day and present your learnings in an ECD forum

Requirements/Qualifications

  • The ability to work independently and proactively with minimal guidance.

  • Proactive, good time management skills, strong organizational, interpersonal skills, and attention to detail.

  • Strong customer focus.

  • Ability to interact well within a team setting.

  • Can communicate and collaborate effectively with junior and senior level professionals.

  • Experience using business tools, including Google Suite, Word, Excel, PowerPoint; experience with Sharepoint, Tableau, or Qlik a plus.

  • Some drug development experience, particularly in clinical research, is a plus.

At this time, 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.

Who We Are

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.

The next step is yours. To apply today, click on the "Apply for this job" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

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