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Clinical Biomarker Project Manager California
4/14/2014 12:15 PM

The Clinical Biomarker Project Manager will manage biomarker activities within Translational Medicine and will be accountable for the successful operational planning, execution and handling of translational medicine activities for the various projects. Key Accountabilities/Core Job Responsibilities: • Manage relationships with external analytical labs, provide input into trial-specific agreem  ...View Job
Manager/Sr. Manager, Regulatory Affairs California
4/10/2014 4:58 PM

General Position Summary/Purpose: Actively contributes in the development and implementation of regulatory strategies for product development and approval. Responsible for specific regulatory document, submission, and compliance issues. Provide regulatory support to other departments, project teams, and committees in managing the development of Pharmacyclics’s products. Interaction with FDA re  ...View Job
Manager/Sr. Manager, CMC, Regulatory Affairs California
4/7/2014 4:18 PM

The Manager/Senior Manager actively contributes in the development and implementation of regulatory strategies for product development and approval. Responsible for specific regulatory document, submission, and compliance issues. Provides regulatory support to other departments, project teams, and committees in managing the development of Pharmacyclics’s products. Interaction with FDA represent  ...View Job
Sr Manager , Scientific & Technical Publishing (SSF) California
4/7/2014 4:15 PM

General Position Summary/Purpose: Manager/Sr. Manager, Regulatory Publishing is responsible for the publication of regulatory documents according to regulatory authority specifications and department standards for paper and electronic submissions. This person assists in the development of electronic submissions standards and tools. The Manager/Sr. Manager, Regulatory Publishing also coordinates  ...View Job
Senior Quality Specialist, Audit California-Silicon Valley/San Jose
4/1/2014 10:02 AM

Performs internal and external GMP and Quality System audits and ensures follow up on audit observations. Maintains audit schedule and ensures audits are performed when planned. Provides metrics to management regarding compliance of audited sites. Key Accountabilities/Core Job Responsibilities: • Execute audits in accordance with established audit processes. • Maintain audit schedule to ensur  ...View Job
Manager, Clinical Supply Chain California
3/20/2014 4:15 PM

General Position Summary/Purpose: Manage global clinical drug supply activities (secondary packaging vendor selection, technical batch record review, clinical label design, label translation coordination, packaging and labeling, IXRS oversight, distribution tracking, product returns and destruction coordination. Manage secondary packaging vendors to ensure timelines are met. Provide Supply upda  ...View Job
Analytical Scientist California
3/20/2014 4:12 PM

A Scientist II in the Analytical Chemistry department must have extensive experience in developing and validating analytical test methods for small molecule drug substances and drug products. Current knowledge in cGMP, GLP, and ICH and regulatory guidelines required. Communicates experimental results and progress reports verbally and in written form to project teams or CMOs. Hands on experience w  ...View Job