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Lead Specialist in Medical Affairs Governance and Quality

2 months ago

San Mateo, California, United States ACL Digital Full time

Job Title: Manager of Medical Governance and R&D Quality Assurance

Location: Hybrid work model

Description:

Key Responsibilities

Assist the Medical Governance team in overseeing the ecosystem of Medical Affairs operations, both internally and externally. This includes, but is not limited to, Self-Assessments/CAPAs, Process Documentation and Training, Management of HCP Arrangements, Monitoring & Reporting, and Document Management.

Self-Assessments and CAPAs


• Facilitate self-assessment initiatives in collaboration with internal business partners.


• Aid in managing responses and corrective actions as necessary.


• Support the resolution of audit findings and the implementation of corrective measures.

Monitoring and Reporting in Medical Governance


• Assist in developing reporting capabilities, including relevant metrics that support Medical Governance operations.


• Identify trends affecting compliance and propose monitoring strategies to evaluate these trends.


• Support routine and ad hoc analysis and reporting.


• Provide assistance and problem-solving support to internal stakeholders regarding monitoring and training challenges.

Management of HCP Arrangements


• Ensure proper documentation of all Medical Affairs HCP engagements and related activities in collaboration with relevant stakeholders.


• Assist in coordinating governance submissions, committee meetings, and documentation of decisions.


• Manage metrics and data reports for the Medical Review Committee and HCP Arrangement Committee, collaborating with Medical Governance to develop presentations for cross-functional stakeholders.


• Maintain Medical Governance document repositories and communication platforms.


• Support monitoring efforts for medical affairs activities in accordance with established processes and relevant regulations.

Cross-Functional Collaboration


• Foster strategic partnerships with cross-functional stakeholders in Medical Affairs, Global Medical Strategy and Operations, Legal, Ethics & Compliance, and R&D Quality.


• Collaborate with various functional groups to enhance Medical Governance as a Quality Business Partner.


• Assist in gathering information necessary to escalate critical issues to appropriate levels.

Promoting a Culture of Compliance


• Build trusted relationships with Medical Affairs associates to encourage a culture of accountability and compliance.


• Ensure documentation completeness and currency that outlines policy and process practices across Medical Affairs activities.


• Advocate for a culture centered on quality, compliance, and patient focus.

Qualifications


• Bachelor’s degree required.


• Relevant experience in the biopharmaceutical or related industry is advantageous.


• General understanding of industry regulations and standards.


• Strong organizational and project management capabilities.


• Proven critical thinking skills with the ability to define and implement compliance standards and practices.


• Effective communication and interpersonal skills, with the ability to develop relationships across various organizational levels.


• Required experience: Entry-level, with at least 1 year in a relevant role.

Essential Skills:


• Strong organizational skills.


• Ability to collaborate across functions.


• Proficiency in computer applications.

Preferred Skills:


• Experience in a pharmaceutical organization.


• Data analytics skills.


• Proficiency in creating presentations.

Unique Opportunity:


• Engage with multiple stakeholders within the organization.

Required Degree:


• Bachelor’s degree.