Associate Manager - Medical Information*

Senior Manager, Medical & Affiliates, R&D QualityLeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world. Location: Parsippany, NJ 07054 Duration: 6 months Payrate: $55/hr - $68/hr on W2Job Description:Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your pharma business expertise to partner with internal teams and external partners as we strive to cure unmet medical needs?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.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 ResponsibilitiesPartner 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 documentationCreating analytic tools to enhance data insights and leadership communicationsSupporting initiatives and projects led by Quality Business Partners in collaboration with the businessDeveloping sophisticated presentations to support project execution and decision makingThe role requires the ability to remain flexible and effectively manage multiple priorities simultaneously. Pharmaceutical industry experience is preferred.Audits, Inspections & Self-AssessmentsSupport team needs in their conduct audits, inspections, and self-assessment activities in coordination with functional business partnersSupport internal audit and regulatory inspection deliverables, including readiness preparation, inspection execution, and response activities, as neededAssist with the resolution of relevant audit and inspection findings and the implementation of corrective actionsMedical Governance Monitoring & ReportingSupport 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 operationsProactively identify trends influencing Gilead's overall compliance and propose monitoring and auditing tactics to further assess and evaluate trendsSupport monitoring and routine/ad hoc analysis and reportingAssist in providing day-to-day guidance, support and problem solving to internal stakeholders regarding monitoring and training issuesOversee monitoring, tracking, reporting, and communications to ensure compliance with required trainingCross-functional PartnerSupport strategic partnerships with our cross functional stakeholders including Medical Affairs, Global Medical Strategy and Operations, Affiliates, Legal, Ethics &Compliance, and R&D QualityWork 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 PartnerSupport the gathering of information necessary to escalate an issue of critical importance or controversy to the appropriate levelsMedical Governance and Affiliates Compliance CultureDevelop trusted relationships with Medical Affairs associates and Affiliate partners at all levels to promote an accountable complaint cultureAssure completeness and currency of documentation that describe policy and process practices across Medical Affairs activities and AffiliatesPromote a culture of quality, compliance and patient centricityQualificationsBA/BS with 3+ years' relevant experience.Relevant experience in quality, compliance, governance and risk management in the biopharmaceutical or related industryDemonstrated critical thinking skillsFamiliarity with post-marketing medical affairs operations and activitiesGeneral understanding of the PhRMA code regulations, standards, and business requirementsEffective communication and interpersonal skillsExcellent organizational and project management skillsDemonstrated 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 activitiesEffective communication and interpersonal skills, to include developing relationships across organizational levelsExcellent organizational and project management skillsPrevious people-management experience and a track record of effective leadership, whether through direct line or matrix team management.