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Medical Affairs Manager

3 months ago

Foster City, United States LeadStack Inc. Full time

Job Title: Medical Governance, R&D Quality Manager

Duration- 6 months - 1 year

Location- FC hybrid onsite 3 days a weeks and 2 days remote

PR: $55/hr to $60/hr


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 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

Required Degree or Certification: BS degree.