Senior Clinical Drug Supply Associate

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:

• Manage global clinical drug supply activities to ensure available drug supply for ongoing studies. Responsibilities include:
• Perform technical batch record review.
• Coordinate destruction and reconciliation of investigational products (IP).
• Perform temperature excursion evaluation and trend management.
• Assist in completing shipment requests, sample submissions and packaging/labeling requests.
• Run scheduled reports from IRT and other inventory systems.
• Provide additional study management support.
• Act as the SPOC (Single Point of Contact) for management of Trial Master File (TMF). Responsibilities include:
• Collect and submit required documents for clinical studies for TMF / eTMF filing.
• Track review dates and ensure on time completion.
• Maintain a proper archival and retention process of the TMF artifacts.
• Reconcile any missing artifacts.

Qualifications:

• Minimum of 3 years of experience in Pharmaceutical GMP clinical supply chain, Operations, Quality Assurance, Clinical Operations, or program management or College degree
• Understanding of cGMPs and pharmaceutical industry procedures and regulations
• Ability to plan and organize with good time management capabilities
• Strong, open and transparent communication skills (verbal and written)
• Strong organizational and time management skills
• Robust project management skills and computer proficiency
• Experience with MS Excel, Word, MS Project, and MS Powerpoint is a plus

Education Requirements (degree, certifications, etc.):

• Bachelor's degree in biological sciences or equivalent.

#LI-SH19

Equal Opportunity Employer Minorities/Women/Veterans/Disabled