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Global Clinical Submissions Quality Lead, Senior Director - Full-time / Part-time
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Cambridge, Massachusetts |
About this job
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Role Description
The Global Clinical Submissions Quality Lead develops, oversees and executes strategies and plans to ensure that clinical components and clinical data included in submissions to regulators are complete and accurate and meet global regulatory requirements and internal quality standards, procedures and business objectives. Expertise in clinical development and understanding data and tables for regulatory purposes are fundamental to the position.
Major components of this role are strategic leadership and championing of quality in clinical documents for regulatory submissions, working directly with teams and team leaders to achieve quality goals, and establishing submission-specific quality strategies to meet stakeholder requirements.
This role is core to quality in clinical documents and the continuous improvement of performance, quality standards and knowledge management, including instituting best practices and applying learning across the portfolio in Global Innovative Pharma, Global Established Pharma, and Vaccines, Oncology, and Pfizer Consumer Healthcare.
This role champions a culture of quality in clinical development, compliance, ownership, and teamwork, and reinforces execution of quality goals and deliverables across regulatory submissions. Moreover, the role emphasizes innovation and the use of technology to maximize efficiency and accuracy.
Global Clinical Submissions Quality Leads will work predominantly with business segment teams to achieve quality goals and enhance a quality culture.
Responsibilities
The Global Clinical Submissions Quality Lead will have key accountability for the quality of clinical components and clinical data within submissions to regulators. Primary duties include the following:
Quality Clinical Components and Clinical Documents in Regulatory Submissions:
* Leads strategies for quality of clinical data for multiple regulatory submissions and maintains optimal processes to ensure clinical data quality in submissions - including dossiers, other submission documents, presentations, and responses to regulatory authority queries.
* Ensures that an Integrated QC Plan is in place for appropriate submissions.
* Oversees the planning, execution and delivery of quality strategies and plans for clinical data in regulatory submissions globally, including New Drug Applications (NDA), Biologics Licensing Applications (BLA), Marketing Authorization Applications (MAA) and related supplements.
* Ensures adherence to submission-specific standards and controls; oversees development and execution against submission-specific quality plans.
* Ensures optimal and timely escalation of issues for resolution.
* Acts as a key decision-maker on submission readiness in accordance with established quality standards, controls and requirements and functions as a key point of accountability for signing-off clinical data quality within appropriate submissions.
* Ensures adequate communication of ongoing status.
* Coordinates with lines contributing clinical data, and associated outputs, to develop and communicate submission-specific clinical data QC strategy, including the Integrated QC Plan, as appropriate.
o Ensures data/document contributors understand full impact of QC strategy, including QC requirements, timelines and targets for quality of deliverables.
* Identifies obstacles that are not resolvable by teams and facilitates solutions to enable successful submission.
* Pro-actively anticipates challenges, and implements and revises strategies as necessary.
Regulatory Submissions Quality Control Knowledge Management and Continual Improvement:
* Identifies, implements, and communicates best practices for quality management across regulatory submissions processes.
* Identifies emerging regulatory and quality issues and ensures incorporation of new and evolving regulatory requirements regarding data quality across regulatory submissions for sustained compliance with Regulatory Authority requirements and expectations.
* Champions initiatives as needed in support of continual quality improvement of regulatory submissions processes.
* Champions continuous learning and knowledge management with respect to quality issues for use across submissions teams in support of a learning organization.
Qualifications
Technical Skill Requirements
Organizes to achieve key business objectives:
* Understands data and drug development
* Works proactively to enhance quality
* Embraces technology and innovation
* Seeks opportunities to bring clarity and streamline processes
* Knows how to work constructively with teams to get things done both through formal and informal channels
* Identifies new ways of using existing resources/capabilities
* Knows how to problem solve and work collaboratively with other Quality Leads and drug project teams
Qualifications (i.e., preferred education, experience, attributes)
Senior Director: MS, PhD, PharmD, with at least 10 years expertise in drug development, including leadership roles, and subsequent regulatory submissions and hands on knowledge of the drug development and approval processes or equivalent combination of education and experience.
Prior Experience Preferred:
* Experience in clinical development programs and global drug submissions, e.g., New Drug Application (NDA) or Biologic Licensing Application (BLA) and supplemental applications. Knowledge of oncology or immunology is highly useful.
* Experience in one or more of the following: clinical development (Phases 1-3), statistics, project management, medical affairs, and regulatory.
* Experience in pharmaceutical drug development (Proof of Concept through Phase 3) or consumer healthcare products.
* Experience with New Chemical Entity (NCE) and New Biologic Entity (NBE) products or Consumer Healthcare/OTC products.
* Experience supporting products in the marketplace (e.g., Advisory Committee meetings, Post-Marketing Commitments, Product Labeling).
* Outstanding written and oral communication skills and demonstrated ability to communicate well across business lines.
Behavioral Competencies:
Acts Decisively:
* Makes timely and effective decisions by applying business acumen and seeks help quickly for prompt resolution of challenges
* Acts with urgency and removes barriers that hinder productivity
Seizes Accountability:
* Takes personal accountability for outcomes
Insight, Influence, and Inclusion:
* Understands others' unspoken, as well as explicit, concerns
* Adapts own behavior and approach to be more effective, inclusive, and to have positive impact on others
Leads Change:
* Demonstrates perspective and poise through ambiguity and change, and guides others with direction, focus and energy
EEO & Employment Eligibility
Pfizer 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. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Role Description
The Global Clinical Submissions Quality Lead develops, oversees and executes strategies and plans to ensure that clinical components and clinical data included in submissions to regulators are complete and accurate and meet global regulatory requirements and internal quality standards, procedures and business objectives. Expertise in clinical development and understanding data and tables for regulatory purposes are fundamental to the position.
Major components of this role are strategic leadership and championing of quality in clinical documents for regulatory submissions, working directly with teams and team leaders to achieve quality goals, and establishing submission-specific quality strategies to meet stakeholder requirements.
This role is core to quality in clinical documents and the continuous improvement of performance, quality standards and knowledge management, including instituting best practices and applying learning across the portfolio in Global Innovative Pharma, Global Established Pharma, and Vaccines, Oncology, and Pfizer Consumer Healthcare.
This role champions a culture of quality in clinical development, compliance, ownership, and teamwork, and reinforces execution of quality goals and deliverables across regulatory submissions. Moreover, the role emphasizes innovation and the use of technology to maximize efficiency and accuracy.
Global Clinical Submissions Quality Leads will work predominantly with business segment teams to achieve quality goals and enhance a quality culture.
Responsibilities
The Global Clinical Submissions Quality Lead will have key accountability for the quality of clinical components and clinical data within submissions to regulators. Primary duties include the following:
Quality Clinical Components and Clinical Documents in Regulatory Submissions:
* Leads strategies for quality of clinical data for multiple regulatory submissions and maintains optimal processes to ensure clinical data quality in submissions - including dossiers, other submission documents, presentations, and responses to regulatory authority queries.
* Ensures that an Integrated QC Plan is in place for appropriate submissions.
* Oversees the planning, execution and delivery of quality strategies and plans for clinical data in regulatory submissions globally, including New Drug Applications (NDA), Biologics Licensing Applications (BLA), Marketing Authorization Applications (MAA) and related supplements.
* Ensures adherence to submission-specific standards and controls; oversees development and execution against submission-specific quality plans.
* Ensures optimal and timely escalation of issues for resolution.
* Acts as a key decision-maker on submission readiness in accordance with established quality standards, controls and requirements and functions as a key point of accountability for signing-off clinical data quality within appropriate submissions.
* Ensures adequate communication of ongoing status.
* Coordinates with lines contributing clinical data, and associated outputs, to develop and communicate submission-specific clinical data QC strategy, including the Integrated QC Plan, as appropriate.
o Ensures data/document contributors understand full impact of QC strategy, including QC requirements, timelines and targets for quality of deliverables.
* Identifies obstacles that are not resolvable by teams and facilitates solutions to enable successful submission.
* Pro-actively anticipates challenges, and implements and revises strategies as necessary.
Regulatory Submissions Quality Control Knowledge Management and Continual Improvement:
* Identifies, implements, and communicates best practices for quality management across regulatory submissions processes.
* Identifies emerging regulatory and quality issues and ensures incorporation of new and evolving regulatory requirements regarding data quality across regulatory submissions for sustained compliance with Regulatory Authority requirements and expectations.
* Champions initiatives as needed in support of continual quality improvement of regulatory submissions processes.
* Champions continuous learning and knowledge management with respect to quality issues for use across submissions teams in support of a learning organization.
Qualifications
Technical Skill Requirements
Organizes to achieve key business objectives:
* Understands data and drug development
* Works proactively to enhance quality
* Embraces technology and innovation
* Seeks opportunities to bring clarity and streamline processes
* Knows how to work constructively with teams to get things done both through formal and informal channels
* Identifies new ways of using existing resources/capabilities
* Knows how to problem solve and work collaboratively with other Quality Leads and drug project teams
Qualifications (i.e., preferred education, experience, attributes)
Senior Director: MS, PhD, PharmD, with at least 10 years expertise in drug development, including leadership roles, and subsequent regulatory submissions and hands on knowledge of the drug development and approval processes or equivalent combination of education and experience.
Prior Experience Preferred:
* Experience in clinical development programs and global drug submissions, e.g., New Drug Application (NDA) or Biologic Licensing Application (BLA) and supplemental applications. Knowledge of oncology or immunology is highly useful.
* Experience in one or more of the following: clinical development (Phases 1-3), statistics, project management, medical affairs, and regulatory.
* Experience in pharmaceutical drug development (Proof of Concept through Phase 3) or consumer healthcare products.
* Experience with New Chemical Entity (NCE) and New Biologic Entity (NBE) products or Consumer Healthcare/OTC products.
* Experience supporting products in the marketplace (e.g., Advisory Committee meetings, Post-Marketing Commitments, Product Labeling).
* Outstanding written and oral communication skills and demonstrated ability to communicate well across business lines.
Behavioral Competencies:
Acts Decisively:
* Makes timely and effective decisions by applying business acumen and seeks help quickly for prompt resolution of challenges
* Acts with urgency and removes barriers that hinder productivity
Seizes Accountability:
* Takes personal accountability for outcomes
Insight, Influence, and Inclusion:
* Understands others' unspoken, as well as explicit, concerns
* Adapts own behavior and approach to be more effective, inclusive, and to have positive impact on others
Leads Change:
* Demonstrates perspective and poise through ambiguity and change, and guides others with direction, focus and energy
EEO & Employment Eligibility
Pfizer 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. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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