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Associate Manager - Medical Information*

Leadstack Inc

Parsippany, NJ

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JOB DETAILS
SALARY
$60–$68 Per Hour
SKILLS
Alliance/Partner Management, Analysis Skills, Auditing, Biotech and Pharmaceutical, Channel Support, Communication Skills, Corrective Action, Cross-Functional, Document Management, Documentation, Ecosystems, Financial Analysis, Fortune 500 Customers, Health Information Management, Healthcare Quality, Internal Audit, Interpersonal Skills, Leadership, Legal, Maintain Compliance, Marketing, Matrix Management, Medical Affairs, Medical Office Administration, Medical Research, Metrics, Multitasking, Organizational Skills, Patient Safety, Problem Solving Skills, Project Execution, Project/Program Management, Regulations, Regulatory Compliance, Reporting Skills, Research & Development (R&D), Risk Management, Team Lead/Manager, Trend Analysis
LOCATION
Parsippany, NJ
POSTED
30+ days ago
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 Quality
Location: Parsippany, NJ 07054
Duration: 6 months
Payrate: $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 Regards
Akarsh Yathiraj
Senior Recruiter
C. (415) 322-5419
D. (415) 322-5419
A. 611 Gateway Blvd, Ste 120
South San Francisco, CA 94080
W. www.leadstackinc.com

About the Company

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Leadstack Inc