Celgene Associate Director, Operational Analytics & Process Excellence - Drug Safety in Summit, New Jersey
The Associate Director, Operational Analytics & Process Excellence, resides within the Global Safety Operations group of Global Drug Safety & Risk Management (GDSRM) and is a global role based in Summit, NJ reporting to the Snr Director, Global Safety Operations.
The individual provides direct supervision to the Analytics & Process Excellence (APEX) team and is responsible for overseeing operational excellence including but not limited to, management and reporting of quality and compliance metrics across the Global Safety Network, provision of analyses and insights into the effectiveness of pharmacovigilance business processes, issue management (CAPA) and operationalization of pharmacovigilance. Additionally, this individual leads GDSRM participation in industry benchmarking activities used in the evaluation of pharmacovigilance policies, practices, strategies and effectiveness.
Global Drug Safety & Risk Management (GDSRM)/Global Safety Network (GSN)Strategy
•Provide leadership and guidance to Safety Operations (APEX) Personnel in the execution of GDSRM process analytics and process excellence (i.e. business intelligence) activities
•Lead project teams and coordinate activities required to implement GDSRM /GSN initiatives resulting from analytics and process excellence outputs.
•Support management and prioritization of process improvement initiatives
•Act upon metrics based observations; identifying and supporting changes to processes
•Mentor and develop Safety Operations personnel responsible for process analytics and process excellence
•Provision of support and liaison to other functions
ICSR Quality & Compliance Management
•Provide trending of critical compliance and quality related issues (e.g. Late Case Investigations)
•Design and implementation of methodologies for root cause analysis of critical quality and compliance related issues such as Late Case Investigations and erroneous reporting.
•Support regulatory inspections/audits through the generation of listings and analyses related to ICSR quality and compliance
•Ensure routine development and publication of quality and compliance activity reports for distribution to Global Safety Network (GSN) stakeholders
•Contribute to the maintenance of the GDSRM Pharmacovigilance System Quality Manual and Master File.
•Oversee the implementation of requirements/commitments set out in pharmacovigilance agreements between Celgene and its partners, ensuring Celgene remains compliant with all global pharmacovigilance regulations, company policies and procedures
•Oversee the execution of SDEA maintenance activities, which include but are not limited to data reconciliation and quality verification activities
Contracts & Agreements
•Oversee the development and implementation of systems and technologies used for the maintenance and oversight of SDEA obligations and contractual partner performance
•Oversee the production of global metrics and insights used to evaluate the quality, compliance and effectiveness of pharmacovigilance contracts
•Execute root cause analysis and corrective actions for any identified non-compliance or areas of improvement.
•Oversee the tracking and management to closure of GDSRM issues and CAPA investigations and provide metrics for dissemination to GDSRM Senior Leadership and business process owners.
•Apply root cause analysis and problem solving methodologies during system audits and inspections to identify areas for corrective action and process improvements.
•Ensure Inspection readiness by providing detailed insights into areas of risk and approaches for mitigation, in collaboration with subject matter experts and business process owners.
•Represent Global Safety Operations as a Subject Matter Expert during inspections and audits
•Provide “back-room” support during inspections/audits, as required
Safety Data Quality
•Conduct impact analyses and deliver recommendations to the SDQC and where appropriate, the Data Entry Conventions Committee
•Oversee the provision of insights into data quality
Business Process Analytics
•Oversee the tracking and management of GDSRM key performance indicators (KPIs), which include but are not limited to quality and compliance metrics
•Implement KPI, Inspection readiness and quality & compliance dashboards used for the provision of analyses and insights into the effectiveness of pharmacovigilance business processes
•Enable the production of customized metrics and insights, outside of official metrics, as required by senior management
•Conduct continuous evaluation of emerging technologies that may improve departmental efficiency
•Assess and interpret the process impact of regulatory changes
•Propose future directions using innovative techniques derived from insights and understanding of process functioning
•Oversee mechanisms and activities used to compare GDSRM pharmacovigilance activities against industry peers, in order to maintain detailed insight into;
Key business drivers, Strategic objectives, Technology strategies and tools, Cost and resource allocation
•Identify opportunities for improving performance
•Manage the process for annual industry benchmarking activities
Master’s level degree (or Bachelor’s Degree with relevant experience) in medical or life sciences, or a combination of relevant education or professional experience
Minimum eight (8) years pharmaceutical/biotechnology drug safety experience preferred.
Experience of managing teams preferable
Quality & Compliance / Analytics & Process Improvement
•Good understanding of the need for data accuracy, completeness, consistency and integrity.
•Ability to understand the implication of lack of compliance for regulated processes
•Appreciation of the link between medical services, quality assurance, customer service and drug safety
•Understanding of the application of six-sigma and other techniques and tools for process improvement
•Ability to lead complex, strategic projects (cross-functional, cross Business Unit/Shared Service Unit)
•Understanding of statistical techniques for data analysis
•Ability to draw out main messages from data, analysis and research, and identify essential supporting information.
•Strong organizational and planning skills required including development and execution of project plans.
•Must have ability to work independently on multiple tasks
•Strong problem analysis and negotiation skills
•Experience with the use of the following software/applications types
Microsoft Office Suite, specifically Excel
SharePoint 2010 or above
SAP Business Objects, Oracle Business Intelligence (OBIEE) or similar preferred
Data visualization tools (e.g., QlikView, Spotfire or similar) preferred
Enterprise Document Management systems (e.g. Documentum or similar)
•Experience with Microsoft Project preferred
•Technical safety systems including ARISg or similar
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE