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Director, Operational Analytics & Process Excellence Job. Job in Berkeley Heights, New Jersey, United States in Celgene Corporation. Nelest.com
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Director, Operational Analytics & Process Excellence Job

col-narrow-left   

Job ID:

23220

Location:

Berkeley Heights, NJ 

Job function:

Product Development
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director, Operational Analytics & Process Excellence Job

Job Description:

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary

The 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 Berkeley Heights, 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), operationalization of pharmacovigilance agreements and provision of secretariat services to the Safety Data Quality Committee to ensure the quality and integrity of data held within the global safety database. Additionally, this individual leads GDSRM participation in industry benchmarking activities used in the evaluation of pharmacovigilance policies, practices, strategies and effectiveness.

Responsibilities
- 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
- 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.
- Create effective coordination with the work of Safety Operations personnel responsible for the production of Safety Data Exchange Agreements (SDEA's) and other pharmacovigilance contracts
- 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 management and execution of SDEA maintenance activities, which include but are not limited to data reconciliation and quality verification activities
- 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

Job Requirements:


- 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 Ten (10) years pharmaceutical/biotechnology drug safety experience

- Minimum Four (4) years management and / or project management experience

- Experience of managing teams

- Experience in successfully leading Six Sigma and Lean projects

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.

*LI-JW1
J2W:PR

Travel: Yes, 5 % of the Time

Zip Code:

07922

Company Info
Celgene Corporation
86 Morris Avenue
Summit, NJ, United States

Phone: +1-908-673-9000, +41 32 729 85 00, 1-908-673-9800, 1-908-673-9800
Web Site: www.celgene.com

Company Profile

Company Info


Celgene Corporation
86 Morris Avenue
Summit, NJ, United States
Phone: +1-908-673-9000, +41 32 729 85 00, 1-908-673-9800, 1-908-673-9800
Web Site: www.celgene.com

Director, Operational Analytics & Process Excellence Job

col-narrow-left   

Job ID:

23220

Location:

Berkeley Heights, NJ 

Job function:

Product Development
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director, Operational Analytics & Process Excellence Job

Job Description:

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary

The 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 Berkeley Heights, 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), operationalization of pharmacovigilance agreements and provision of secretariat services to the Safety Data Quality Committee to ensure the quality and integrity of data held within the global safety database. Additionally, this individual leads GDSRM participation in industry benchmarking activities used in the evaluation of pharmacovigilance policies, practices, strategies and effectiveness.

Responsibilities
- 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
- 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.
- Create effective coordination with the work of Safety Operations personnel responsible for the production of Safety Data Exchange Agreements (SDEA's) and other pharmacovigilance contracts
- 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 management and execution of SDEA maintenance activities, which include but are not limited to data reconciliation and quality verification activities
- 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

Job Requirements:


- 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 Ten (10) years pharmaceutical/biotechnology drug safety experience

- Minimum Four (4) years management and / or project management experience

- Experience of managing teams

- Experience in successfully leading Six Sigma and Lean projects

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.

*LI-JW1
J2W:PR

Travel: Yes, 5 % of the Time

Zip Code:

07922
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