Intern - Clinical Document Control

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 Document Control (CDC) team to ensure that study documents are properly organized and filed in accordance to SOPs, ICH-GCP guidelines, compliance policies and regulations  

Key Accountabilities/Core Job Responsibilities:

• Assessing the Trial Master File (TMF) content program by program, identifying issues, identifying trends and suggesting potential solutions to prevent the trends of issues seen
  
• Creating / implementing tools that will facilitate TMF remediation efforts
  
• Creating / refreshing / updating / maintaining Sharepoint sites
  
• 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 an 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
  

Preferred Skills/Abilities

On a continuous basis, sit at desk for prolonged period of time at company facility to intermittently answer telephone, file/fax/or copy documents, and write or use a keyboard to communicate through written means. Walking and lifting up to 20 pounds may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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).