Regulatory Affairs Operations Intern

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

Regulatory Affairs Operations summer internship program provides the opportunity to gain first-hand experience with the different functional areas/teams within Regulatory Affairs/ Operations organization as well as broad exposure to various roles within the industry. The program accentuates the growth and development of its participant by providing networking opportunities, career development and involvement in projects that make a significant contribution to the Regulatory Affairs organization.

V alue to Pharmacyclics:

· Understand the various roles, processes and industry standards and provide Regulatory Affairs/Regulatory Operations support

· Develop knowledge of other roles and functions within R&D and cross-functional teams; Apply this knowledge to help support Regulatory Operations function

· Work with the Regulatory Operations team to assist in document management and submission activities, including archiving of Regulatory submissions documentation, including tracking and extracting metrics

· Aptitude to learn the role of Regulatory technology (Regulatory Systems) within Regulatory Affairs organization and the impact within the broader Regulatory, R&D organization

· Support Regulatory Systems and processes including migration/importation of documentation

· Support Submission activities by engaging in day to day tasks (e.g. preparing submission documents, tracking, filing, etc.) associated with submission preparation and dispatch of Regulatory Authority submissions.

· Apply organization skills and collaborate within Regulatory Affairs department

· Contribute to Regulatory and/or cross departmental operational guides and procedures

Education and Other Requirements:

· Must be current college student (sophomore or higher) or recent college graduate with a major in either Life Sciences, Information Technology or Business.

· Strong written, oral and analytical skills

· Adept time management skills

· Proficient in MSOffice programs and Adobe Acrobat

· Technical aptitude; Enjoys learning and working with software applications

Selection Process:

· All candidates must submit current transcripts, a resume and a cover letter describing why they would like to join the Pharmacyclics team, what they hope to gain from the internship and what they offer Pharmacyclics

· Candidates must apply online in order to be considered for the position

Final Presentation

Each Intern is expected to prepare a short presentation to their team to share what they have learned through their internship and how they hope their new knowledge will help them secure their future career. Presentations should be 10-15 minutes long and should include visual aid (posters or PowerPoint).

Equal Opportunity Employer Minorities/Women/Veterans/Disabled