R&D Quality Manager(Medical Governance)

Job Title: Manager, Medical Governance, R&D Quality
Job Location: Foster City, CA (hybrid onsite 3 days a weeks and 2 days remote)
Job Duration: 6 Months (possibility of extension)
Payrate: $60.95/ 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.

Requirements:

• 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.