Senior Manager, Medical & Affiliates, R&D Quality

Job Description

Job Summary:

• 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 Client.
• Seeking a Sr. Manager/Associate Director of Medical & Affiliates Research & Development (R&D) Quality to play a pivotal role in reinforcing and sustaining a strong culture of quality, compliance, governance, and risk management for our cross-therapeutic area medical affairs activities.

Duties and 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 Client’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.

Client Core Values:

• Integrity (always doing the right thing).
• Teamwork (collaborating in good faith).
• Excellence (working at a high level of commitment and capability).
• Accountability (taking personal responsibility).
• Inclusion (encouraging diversity).