Pharmacyclics, LLC

Clinical Quality Management Intern

Location
Sunnyvale, CA, United States
Posted
Apr 24, 2019
Ref
2671
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

General Position Summary/Purpose:

Provide temporary support to members of the Clinical Quality Management (CQM) team with leading clinical quality activities in accordance to SOPs, regulatory agencies and ICH-GCP guidelines

Key Accountabilities/Core Job Responsibilities:

· Assist in the implementation/maintenance/migration of SharePoint

· Assist in the redesign efforts and maintenance of the proposed Clinical Operations Intranet site.

· Assist with the ClinOps CAPA management and workflow process

· Assist in various tracking efforts (CAPA, training, Regional/Field and CRO Clinical Monitor Tracking and Training)

· Assist reconciliation of SOPs with Operational Excellence and CQM

· Assist in the management of 2018/2019 CQM questions, along with metric generation and management

· Assist with CQM Quarterly Newsletter

· Identify and escalate issues appropriately

· Perform other duties as assigned



Qualifications:

· Must have demonstrated strong interest in learning of relevant clinical operations activities

· Working knowledge of Microsoft Office

· Able to prioritize and handle multiple tasks simultaneously

Education Requirements (degree, certifications, etc.):

  • Complete at least second year of university studies prior to internship start date
  • Currently enrolled and in good standing at a US accredited college/university
  • BA/BS in scientific discipline is highly preferred, but not required
  • Maintain a minimum cumulative GPA of 3.0/4.0 or equivalent

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 may be approximately 10-15 minutes long and should include visual aid (posters or PowerPoint).

Equal Opportunity Employer Minorities/Women/Veterans/Disabled