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:
Pharmacyclics is seeking an IT R&D Operations Systems Analyst who will play a critical role in R&D client engagements and in core operational activities for the IT R&D projects.
Accomplishes objectives by designing and monitoring the planning, configuration, and deployment of our Clinical Trials Management System (CTMS), Laboratory Information Management Systems (LIMS), Quality Management Systems and other systems in support of associated core R&D functions and processes. This resource will be the Technical Lead for above systems and will collaborate closely with various R&D Business functions, other IT resources, IT Infrastructure, Project Management, vendors, end users and QA and IT Validation groups .
Strong GxP knowledge, and technical, organization, analytical and communication skills are key to successful performance in this position, which is under the direction of the IT R&D Applications Manager, who provides leadership on each client engagement.
Core Job Responsibilities:
- Technical Lead for GxP applications such as LIMS, CTMS, MasterContol and other similarly classified IT R&D applications
- Oversee R&D administration and operational support including user and security management.
- Lead troubleshooting efforts, root cause analysis and impact assessment of R&D production computer applications
- Work closely with Clinical Apps Manager of IT & R&D Applications to lead initiatives to improve IT R&D effectiveness and efficiency
- Ability to develop solutions to complex problems that require a high degree of ingenuity, creativity, and innovation within the boundaries of industry compliance regulation
- Responsible for maintaining the validated state of IT R&D applications to ensure compliance to regulatory standards
- Responsible for timely closure of IT R&D Exception Reports, CAPAs and Deviations
- Guide IT R&D as Subject Matter Expert (SME) in the event of Regulatory Audits and Inspections
- Leading a team of staff including programmers, analysts, and support specialists
- Implementing and managing security or integrity and backup procedures
- Identify the criticality of selected application functions and the expected service level goals for application operations and support
- Consulting computer users to ascertain needs and to ensure that facilities meet user or project requirements
- Ensuring corporate software licensing policies and procedures are followed
- Testing and modifying systems to ensure that that they operate reliably
- Provide expertise in technologies such as SQL, SharePoint solutions, advanced InfoPath design, Workflows, and web programming languages such as HTML, CSS, XML, Visual Basic, and Java.
- Familiar with drug discovery, translational medicine, and the regulatory submissions process
- Experienced with Enterprise wide LIMS/ CTMS/ QMS implementation and support
- Familiar with Computer System Validation and the Change Control Process in Life sciences industry
- Should be comfortable working with Business Owners, QA, and users across the organization and with differing levels of technical expertise
- Advanced understanding of relational databases, database programming skills and tools
- Strong understanding of the SDLC and Computer System Validation (CSV) and current technology platforms and trends
- Expected to deliver documentation and training with all solutions
- Ability to plan and coordinate multiple simultaneous application efforts
- Quick learner, Analytical and problem-solving skills
- Strong technical skills
- The ability to work well under pressure
- Attention to detail
- Self-starter / tenacious problem solver / highly motivated
- Ability to take projects from design to long-term maintenance
- Ability to work on a team or independently
- Management and leadership capability
- Excellent communication and documentation skills
Qualifications, Experience, and Education Requirements (degree, certifications, etc.):
- Minimum of 5 to 7 years’ experience as a IT R&D Analyst, well-versed with SDLC & iterative systems development methodologies, in the biotech or pharmaceutical industry.
- Strong experience on relational databases, database programming skills and tools
- Technical Expertise on SAS/SQL is highly preferred.
- Strong knowledge of information systems & workflows for processes related to ClinOps, Medical Affairs, CDM, Biostatistics, Clinical Science, and Informatics.
- Responsible for maintaining the validated state of IT R&D applications to ensure compliance to regulatory standard.
- Working knowledge of FDA, EMA regulations such as Annex 11, 21 CFR Part 11, Part 210, 211; Computer Systems Validation and GAMP framework.
- Familiar with electronic ticketing and document management systems such as: Service NOW, Track wise, SharePoint and Microsoft Projects
- Well-developed business partnering & collaboration skills, adept at establishing & sustaining effective working relationships, both within & between departments.
- Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors.
- Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction.
- Education Minimum BA or BS in relevant life science or computer science required. Advanced degree preferred.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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