Associate Manager - Medical Information*

LeadStack 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.Job Titles: Senior Manager, Medical & Affiliates, R&D QualityLocation:  Parsippany, NJ  07054 Duration: 6 monthsPayrate: $55/hr - $68/hr on W2 Job 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 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.

If you have any questions, feel free to call me on (415) 322-5419or send an email on

akarsh.yathiraj@leadstackinc.com

Thanks and RegardsAkarsh Yathiraj

Senior Recruiter

C.	(415) 322-5419
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