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Job Requirements of R&D Quality Manager(Medical Governance):
-
Employment Type:
Contractor
-
Location:
Foster City, CA (Onsite)
Do you meet the requirements for this job?
R&D Quality Manager(Medical Governance)
Careers Integrated Resources Inc
Foster City, CA (Onsite)
Contractor
Job Title: R&D Quality Manager(Medical Governance)
Location- Foster City, CA 94404 (hybrid - onsite 3 days a weeks and 2 days remote)
Duration- 6 months+
Pay range: $54.60 - $60/hr. On W2
Primary Responsibilities:
Support the Medical Governance team to govern the ecosystem of Medical Affairs activities both internally and externally, including but not limited to Self-Assessments/CAPAs, Process Documentation and Training, HCPs Arrangements Management, Monitoring & Reporting, and Document Management
Self Assessments/CAPAs
• Support the conduct of self-assessment activities in coordination with internal business partners
• Support management of response management and corrective actions, as needed
• Assist with the resolution of relevant audit and monitoring findings and the implementation of corrective actions
Medical Governance Monitoring & Reporting:
• Support the development of reporting capabilities, including relevant metrics R&D Quality possesses or can develop that reflect to support Medical Governance operations
• Proactively identify trends influencing Client’s overall compliance and propose monitoring and auditing tactics to assess and evaluate trends
• Support monitoring and routine/ad hoc analysis and reporting
• Assist in providing support and problem solving to internal stakeholders regarding monitoring and training issues
HCP Arrangements
• Ensure appropriate documentation of all Medical Affairs HCP engagement and other relevant activities in partnership with relevant stakeholders
• Assist with the coordination of governance submissions, Committee meetings and documentation of decisions
• Manage metric and data reports on behalf of the Medical Review Committee and HCP Arrangement Committee and partner with the Medical Governance; develop presentations for cross-functional stakeholders
• Maintain Medical Governance document repositories, communications, and Medical Governance information sites
• Support the monitoring efforts for medical affairs activities and the execution of such in accordance with the Medical Governance Committee process and other relevant regulations, standards, policies, and procedures
Cross-functional Partner
• Support strategic partnerships with our cross functional stakeholders in Medical Affairs, Global Medical Strategy and Operations, Legal, Ethics &Compliance, and R&D Quality
• Work collaboratively with other functional groups and relevant stakeholders to advance the Medical Governance 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 Compliance Culture
• Develop trusted relationships with Medical Affairs associates 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
• Promote a culture of quality, compliance and patient centricity
Qualifications
• BA/BS
• Relevant experience in the biopharmaceutical or related industry is a plus
• General understanding of the PhRMA code regulations, standards, and business requirements
• Excellent organizational and project management skills
• Demonstrated critical thinking skills and ability to define and implement 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
Required Years of Experience: 1 year- Entry Level
Top 3 Required Skill Sets: Strong organizational skills; Ability to collaborate cross functionally; Computer literate
Top 3 Nice to Have Skill Sets: Pharmaceutical organization experience; data analytics skills; PowerPoint presentation skills
Unique Selling Point of this role: Opportunity to work with several Client stakeholders
Required Degree or Certification: BS degree.
Location- Foster City, CA 94404 (hybrid - onsite 3 days a weeks and 2 days remote)
Duration- 6 months+
Pay range: $54.60 - $60/hr. On W2
Primary Responsibilities:
Support the Medical Governance team to govern the ecosystem of Medical Affairs activities both internally and externally, including but not limited to Self-Assessments/CAPAs, Process Documentation and Training, HCPs Arrangements Management, Monitoring & Reporting, and Document Management
Self Assessments/CAPAs
• Support the conduct of self-assessment activities in coordination with internal business partners
• Support management of response management and corrective actions, as needed
• Assist with the resolution of relevant audit and monitoring findings and the implementation of corrective actions
Medical Governance Monitoring & Reporting:
• Support the development of reporting capabilities, including relevant metrics R&D Quality possesses or can develop that reflect to support Medical Governance operations
• Proactively identify trends influencing Client’s overall compliance and propose monitoring and auditing tactics to assess and evaluate trends
• Support monitoring and routine/ad hoc analysis and reporting
• Assist in providing support and problem solving to internal stakeholders regarding monitoring and training issues
HCP Arrangements
• Ensure appropriate documentation of all Medical Affairs HCP engagement and other relevant activities in partnership with relevant stakeholders
• Assist with the coordination of governance submissions, Committee meetings and documentation of decisions
• Manage metric and data reports on behalf of the Medical Review Committee and HCP Arrangement Committee and partner with the Medical Governance; develop presentations for cross-functional stakeholders
• Maintain Medical Governance document repositories, communications, and Medical Governance information sites
• Support the monitoring efforts for medical affairs activities and the execution of such in accordance with the Medical Governance Committee process and other relevant regulations, standards, policies, and procedures
Cross-functional Partner
• Support strategic partnerships with our cross functional stakeholders in Medical Affairs, Global Medical Strategy and Operations, Legal, Ethics &Compliance, and R&D Quality
• Work collaboratively with other functional groups and relevant stakeholders to advance the Medical Governance 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 Compliance Culture
• Develop trusted relationships with Medical Affairs associates 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
• Promote a culture of quality, compliance and patient centricity
Qualifications
• BA/BS
• Relevant experience in the biopharmaceutical or related industry is a plus
• General understanding of the PhRMA code regulations, standards, and business requirements
• Excellent organizational and project management skills
• Demonstrated critical thinking skills and ability to define and implement 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
Required Years of Experience: 1 year- Entry Level
Top 3 Required Skill Sets: Strong organizational skills; Ability to collaborate cross functionally; Computer literate
Top 3 Nice to Have Skill Sets: Pharmaceutical organization experience; data analytics skills; PowerPoint presentation skills
Unique Selling Point of this role: Opportunity to work with several Client stakeholders
Required Degree or Certification: BS degree.
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