Senior Manager, Medical & Affiliates, R&D Quality

Net2Source

New Jersey, NJ

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JOB DETAILS

SALARY

$68.33–$69 Per Hour

SKILLS

Agile Programming Methodologies, Alliance/Partner Management, Analysis Skills, Auditing, Biotech and Pharmaceutical, Channel Support, Communication Skills, Corrective Action, Cross-Functional, Document Management, Documentation, Ecosystems, Financial Analysis, Healthcare Quality, Industry/Trade Analysis, 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

New Jersey, NJ

POSTED

30+ days ago

Join a Global Leader in Workforce Solutions – Net2Source Inc.
Who We Are
Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.

Job Title: Senior Manager, Medical & Affiliates, R&D Quality
Duration- 6 months contract
Location- Parsippany New Jersey/USA/07054

Job description
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 client. The role requires the ability to remain flexible and effectively manage multiple priorities simultaneously. Pharmaceutical industry experience is preferred.

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

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 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

Why Work With Us?
We believe in more than just jobs—we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter.

Our Commitment to Inclusion & Equity
Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.

Awards & Recognition
• America's Most Honored Businesses (Top 10%)
• Fastest-Growing Staffing Firm by Staffing Industry Analysts
• INC 5000 List for Eight Consecutive Years
• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1
Ready to Level Up Your Career?]

About the Company

Net2Source

Net2Source Inc. is a Global Workforce Management Solutions Company, headquartered in New Brunswick, NJ with its local offices in Texas, California, Florida, Illinois, Colorado and Michigan and its global operations in Canada, UK, Europe, UAE, Malaysia, Australia, China, Singapore and India. Net2Source offers a wide gamut of consulting solutions customized to specific client needs including but not limited to Application Development, Workforce Management and Project Consulting. Whether it’s a Fortune client, whether it’s a System Implementer or whether it is a Start -up, our recipe to success – Exceed expectations! Under promise, over deliver.

COMPANY SIZE

50 to 99 employees

INDUSTRY

Other/Not Classified

WEBSITE

http://www.net2source.com

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