Clinical Quality Management Intern
- Employer
- Pharmacyclics, LLC
- Location
- Sunnyvale, CA, United States
- Start date
- Apr 24, 2019
View more
- Discipline
- Clinical, Clinical Research, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
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
Company
Pharmacyclics LLC, a wholly-owned subsidiary of AbbVie (NYSE: ABBV), is focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immunemediated diseases. Pharmacyclics’ mission is to develop and commercialize novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical needs. Pharmacyclics markets IMBRUVICA and has two product candidates in clinical development and several preclinical molecules in lead optimization. Pharmacyclics is committed to high standards of ethics, scientific rigor and operational efficiency as it moves each of these programs toward commercialization. To learn more, please visit www.pharmacyclics.com.
- Website
- http://www.pharmacyclics.com/
- Mini-site
- Pharmacyclics, LLC
- Phone
- 408-774-0330
- Location
-
995 East Arques Avenue
Sunnyvale
California
94086
US
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