Intern – Product Development Regulatory Documentation
United States of America
Job ID: 202106-116363 (http://jobs.gene.com/202106-116363)
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Start Date: (September) Fall 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.
Product Development Regulatory Documentation (PDRD) :
PDRD Works closely with cross-functional teams to prepare regulatory documents for submission to regulatory authorities within subject areas (clinical/safety). Our department is responsible for the scheduling, process management, and preparation of quality regulatory documents to support clinical development programs and license applications and license maintenance in a matrix team environment in accordance with regulatory guidance and timelines. Well-written documents are the key to successful partnership with Health Authorities.
Qualifications & Experience:
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 preferably with academic experience in Regulatory, Science, or Pharmacy fields. Candidates may be Master’s, PhD, PharmD, MBA graduates, but those degrees are not required.
Intern Project Overview and Responsibilities
Some skills, qualifications, and abilities a candidate will need to thrive in an internship within PDR are:
Ability to work on multiple projects with various cross-functional teams to prepare regulatory documents for submission to regulatory authorities. This includes the scheduling, process management, and preparation of quality regulatory documents to support clinical development programs and license applications and license maintenance in accordance with regulatory guidance and timelines.
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
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.
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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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