Sr. Manager/Associate Director -Medical affairs
Parsippany-Troy Hills, NJ, United States
Contract
3 days ago
$80 - $85 USD
Key skills
RBusiness IntelligenceSaaSERPLeadershipProject ManagementRisk ManagementCommunicationDecision MakingCritical ThinkingProblem SolvingCollaborationSales
About this role
About Nexinfo:
NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. We aims to help businesses across industries achieve their goals through industry best practices, lean process design,
and advanced software solutions. Their ERP-related services address challenges such as inventory management, product lifecycle management, demand management, forecasting, sales and operations planning, business intelligence, security compliance, and financial alignment.
Job Title: Sr. Manager/Associate Director ,Medical & Affiliates, R&D Quality
Location: Parsippany, NJ (hybrid)
Contract
The Sr. Manager/Associate Director will support Medical & Affiliates R&D Quality operations by promoting document management, monitoring initiatives, independent projects and learning solutions that are managed by R&D Quality Process, Documentation and Learning to advance a culture of quality and compliance across Gilead.
Primary Responsibilities
Partner with Medical & Affiliates Quality Business Partner team to support the ecosystem of medical affairs and Affiliates quality operations, including:
Synthesizing Quality issues arising from deviations, inspections, and audits; supporting the development and maintenance of Medical Affairs (MA) process documentation
Creating analytic tools to enhance data insights and leadership communications
Supporting initiatives and projects led by Quality Business Partners in collaboration with the business
Developing sophisticated presentations to support project execution and decision making
The role requires the ability to remain flexible and effectively manage multiple priorities simultaneously. Pharmaceutical industry experience is preferred.
Audits, Inspections & Self-Assessments
Support team needs in their conduct audits, inspections, and self-assessment activities in coordination with functional business partners
Support internal audit and regulatory inspection deliverables, including readiness preparation, inspection execution, and response activities, as needed
Assist with the resolution of relevant audit and inspection findings and the implementation of corrective actions
Medical Governance Monitoring & Reporting
Support the development of reporting capabilities, including an understanding of what metrics R& D Quality possesses, or can develop, that reflect the needs of Medical Governance & Affiliates operations
Proactively identify trends influencing Gilead s overall compliance and propose monitoring and auditing tactics to further assess and evaluate trends
Support monitoring and routine/ad hoc analysis and reporting
Assist in providing day-to-day guidance, support and problem solving to internal stakeholders regarding monitoring and training issues
Oversee monitoring, tracking, reporting, and communications to ensure compliance with required training
Cross-functional Partner
Support strategic partnerships with our cross functional stakeholders including Medical Affairs, Global Medical Strategy and Operations, Affiliates, Legal, Ethics &Compliance, and R&D Quality
Work collaboratively with other functional groups and relevant stakeholders, e.g., Regulatory Affairs and Patient Safety to advance the Medical Governance and Affiliate role as a Quality Business Partner
Support the gathering of information necessary to escalate an issue of critical importance or controversy to the appropriate levels
Medical Governance and Affiliates Compliance Culture
Develop trusted relationships with Medical Affairs associates and Affiliate partners at all levels to promote an accountable complaint culture
Assure completeness and currency of documentation that describe policy and process practices across Medical Affairs activities and Affiliates
Promote a culture of quality, compliance and patient centricity
Qualifications
BA/BS with 3+ years relevant experience.
Relevant experience in quality, compliance, governance and risk management in the biopharmaceutical or related industry
Demonstrated critical thinking skills
Familiarity with post-marketing medical affairs operations and activities
General understanding of the PhRMA code regulations, standards, and business requirements
Effective communication and interpersonal skills
Excellent organizational and project management skills
Demonstrated critical thinking skills and ability to define and implement quality and compliance constructs, standards, metrics, and practices that drive quality and compliance across cross-functional operations and activities
Effective communication and interpersonal skills, to include developing relationships across organizational levels
Excellent organizational and project management skills
Previous people-management experience and a track record of effective leadership, whether through direct line or matrix team management
Primary Responsibilities
Partner with Medical & Affiliates Quality Business Partner team to support the ecosystem of medical affairs and Affiliates quality operations, including:
Synthesizing Quality issues arising from deviations, inspections, and audits; supporting the development and maintenance of Medical Affairs (MA) process documentation
Creating analytic tools to enhance data insights and leadership communications
Supporting initiatives and projects led by Quality Business Partners in collaboration with the business
Developing sophisticated presentations to support project execution and decision making
The role requires the ability to remain flexible and effectively manage multiple priorities simultaneously. Pharmaceutical industry experience is preferred.
Audits, Inspections & Self-Assessments
Support team needs in their conduct audits, inspections, and self-assessment activities in coordination with functional business partners
Support internal audit and regulatory inspection deliverables, including readiness preparation, inspection execution, and response activities, as needed
Assist with the resolution of relevant audit and inspection findings and the implementation of corrective actions
Medical Governance Monitoring & Reporting
Support the development of reporting capabilities, including an understanding of what metrics R& D Quality possesses, or can develop, that reflect the needs of Medical Governance & Affiliates operations
Proactively identify trends influencing Gilead s overall compliance and propose monitoring and auditing tactics to further assess and evaluate trends
Support monitoring and routine/ad hoc analysis and reporting
Assist in providing day-to-day guidance, support and problem solving to internal stakeholders regarding monitoring and training issues
Oversee monitoring, tracking, reporting, and communications to ensure compliance with required training
Cross-functional Partner
Support strategic partnerships with our cross functional stakeholders including Medical Affairs, Global Medical Strategy and Operations, Affiliates, Legal, Ethics &Compliance, and R&D Quality
Work collaboratively with other functional groups and relevant stakeholders, e.g., Regulatory Affairs and Patient Safety to advance the Medical Governance and Affiliate role as a Quality Business Partner
Support the gathering of information necessary to escalate an issue of critical importance or controversy to the appropriate levels
Medical Governance and Affiliates Compliance Culture
Develop trusted relationships with Medical Affairs associates and Affiliate partners at all levels to promote an accountable complaint culture
Assure completeness and currency of documentation that describe policy and process practices across Medical Affairs activities and Affiliates
Promote a culture of quality, compliance and patient centricity
Qualifications
BA/BS with 3+ years relevant experience.
Relevant experience in quality, compliance, governance and risk management in the biopharmaceutical or related industry
Demonstrated critical thinking skills
Familiarity with post-marketing medical affairs operations and activities
General understanding of the PhRMA code regulations, standards, and business requirements
Effective communication and interpersonal skills
Excellent organizational and project management skills
Demonstrated critical thinking skills and ability to define and implement quality and compliance constructs, standards, metrics, and practices that drive quality and compliance across cross-functional operations and activities
Effective communication and interpersonal skills, to include developing relationships across organizational levels
Excellent organizational and project management skills
Previous people-management experience and a track record of effective leadership, whether through direct line or matrix team management