What are the responsibilities and job description for the Associate Manager - Medical Information position at Advanced Clinical?
OVERVIEW
We are currently seeking a highly motivated Associate Manager Medical Information to join a well-known client’s team onsite in Parsippany, New Jersey. This role will play a pivotal part in reinforcing and sustaining a strong culture of quality, compliance, governance, and risk management across cross-therapeutic area medical affairs activities.
This position supports Medical & Affiliates R&D Quality operations through leadership in document management, monitoring initiatives, analytics, and learning solutions. The individual will collaborate cross-functionally to drive quality excellence and ensure compliance across the organization, making a direct impact on patient-focused outcomes and the broader biopharmaceutical industry.
RESPONSIBILITIES
• Partner with Medical & Affiliates Quality Business Partners to support quality operations across Medical Affairs and Affiliate activities.
• Synthesize quality issues arising from deviations, audits, and inspections, and support the development and maintenance of Medical Affairs process documentation.
• Develop analytical tools and reporting capabilities to enhance data insights and leadership communications.
• Support projects and initiatives led by Quality Business Partners in collaboration with cross-functional teams.
• Create and deliver high-impact presentations to support decision-making and project execution.
Audits, Inspections & Self-Assessments
• Support audit, inspection, and self-assessment activities in coordination with functional partners.
• Assist with inspection readiness, execution, and response activities.
• Contribute to the resolution of audit findings and implementation of corrective and preventive actions (CAPAs).
Medical Governance Monitoring & Reporting
• Support development of metrics, dashboards, and reporting strategies aligned with Medical Governance and Affiliate operations.
• Identify compliance trends and propose monitoring and auditing strategies to mitigate risk.
• Conduct routine and ad hoc reporting and analysis.
• Provide day-to-day support to stakeholders on monitoring and training compliance.
• Oversee tracking and communication of required training compliance.
Cross-Functional Collaboration
• Partner with stakeholders across Medical Affairs, Global Medical Strategy & Operations, Affiliates, Legal, Ethics & Compliance, Regulatory Affairs, Patient Safety, and R&D Quality.
• Support issue escalation processes for critical compliance or governance matters.
• Strengthen Medical Governance and Affiliate partnerships through effective collaboration.
Quality Culture & Compliance
• Build trusted relationships to promote a culture of accountability, quality, and compliance.
• Ensure completeness and accuracy of policy and process documentation across Medical Affairs and Affiliate activities.
• Promote patient centricity and continuous improvement in quality practices.
EXPERIENCE
• Minimum of 3 years of relevant experience in quality, compliance, governance, or risk management within the biopharmaceutical or related industry.
• Experience supporting audits, inspections, and quality systems in a regulated environment preferred.
• Familiarity with post-marketing Medical Affairs operations and activities.
• Working knowledge of PhRMA Code regulations, standards, and business requirements.
• Demonstrated experience in data analytics, reporting, and quality metrics development.
• Proven leadership experience, including direct or matrix team management.
EDUCATION
• Bachelor’s degree in a relevant discipline required.
TO BE A BEST FIT, YOUR STRENGTHS MUST INCLUDE
• Strong critical thinking skills with the ability to define and implement quality and compliance frameworks.
• Excellent communication and interpersonal skills, with the ability to influence across all organizational levels.
• Strong organizational and project management capabilities, with the ability to manage multiple priorities simultaneously.
• Analytical mindset with experience developing insights from complex data.
• Ability to work effectively in a dynamic, cross-functional, and fast-paced environment.
• Proven ability to build relationships and drive collaboration across stakeholders.
We are currently seeking a highly motivated Associate Manager Medical Information to join a well-known client’s team onsite in Parsippany, New Jersey. This role will play a pivotal part in reinforcing and sustaining a strong culture of quality, compliance, governance, and risk management across cross-therapeutic area medical affairs activities.
This position supports Medical & Affiliates R&D Quality operations through leadership in document management, monitoring initiatives, analytics, and learning solutions. The individual will collaborate cross-functionally to drive quality excellence and ensure compliance across the organization, making a direct impact on patient-focused outcomes and the broader biopharmaceutical industry.
RESPONSIBILITIES
• Partner with Medical & Affiliates Quality Business Partners to support quality operations across Medical Affairs and Affiliate activities.
• Synthesize quality issues arising from deviations, audits, and inspections, and support the development and maintenance of Medical Affairs process documentation.
• Develop analytical tools and reporting capabilities to enhance data insights and leadership communications.
• Support projects and initiatives led by Quality Business Partners in collaboration with cross-functional teams.
• Create and deliver high-impact presentations to support decision-making and project execution.
Audits, Inspections & Self-Assessments
• Support audit, inspection, and self-assessment activities in coordination with functional partners.
• Assist with inspection readiness, execution, and response activities.
• Contribute to the resolution of audit findings and implementation of corrective and preventive actions (CAPAs).
Medical Governance Monitoring & Reporting
• Support development of metrics, dashboards, and reporting strategies aligned with Medical Governance and Affiliate operations.
• Identify compliance trends and propose monitoring and auditing strategies to mitigate risk.
• Conduct routine and ad hoc reporting and analysis.
• Provide day-to-day support to stakeholders on monitoring and training compliance.
• Oversee tracking and communication of required training compliance.
Cross-Functional Collaboration
• Partner with stakeholders across Medical Affairs, Global Medical Strategy & Operations, Affiliates, Legal, Ethics & Compliance, Regulatory Affairs, Patient Safety, and R&D Quality.
• Support issue escalation processes for critical compliance or governance matters.
• Strengthen Medical Governance and Affiliate partnerships through effective collaboration.
Quality Culture & Compliance
• Build trusted relationships to promote a culture of accountability, quality, and compliance.
• Ensure completeness and accuracy of policy and process documentation across Medical Affairs and Affiliate activities.
• Promote patient centricity and continuous improvement in quality practices.
EXPERIENCE
• Minimum of 3 years of relevant experience in quality, compliance, governance, or risk management within the biopharmaceutical or related industry.
• Experience supporting audits, inspections, and quality systems in a regulated environment preferred.
• Familiarity with post-marketing Medical Affairs operations and activities.
• Working knowledge of PhRMA Code regulations, standards, and business requirements.
• Demonstrated experience in data analytics, reporting, and quality metrics development.
• Proven leadership experience, including direct or matrix team management.
EDUCATION
• Bachelor’s degree in a relevant discipline required.
TO BE A BEST FIT, YOUR STRENGTHS MUST INCLUDE
• Strong critical thinking skills with the ability to define and implement quality and compliance frameworks.
• Excellent communication and interpersonal skills, with the ability to influence across all organizational levels.
• Strong organizational and project management capabilities, with the ability to manage multiple priorities simultaneously.
• Analytical mindset with experience developing insights from complex data.
• Ability to work effectively in a dynamic, cross-functional, and fast-paced environment.
• Proven ability to build relationships and drive collaboration across stakeholders.
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.
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