Senior Manager, Patient Engagement


Published
June 3, 2019
Location
One Edwards Way, California
Category
Job Type
Job Level
Manager or Senior Manager

Description

The Senior Manager, Patient Engagement develops and implements Edwards’ patient insight data collection and dissemination capabilities to support the development of medical devices at various stages of the total product lifecycle, with special emphasis on science-based advocacy and policy decision-making.    Manages Edwards’ strategy to advocate for patient-centric regulatory and reimbursement policies in healthcare systems throughout the world.
 
Job Function:
Management of Patient Insight Data Collection and Dissemination:
  • Engage internal stakeholders (e.g., strategy, R&D, clinical, medical affairs, regulatory, health economics, marketing) to identify opportunities to incorporate patient insights into the total product lifecycle
  • Ensure that patient insight efforts are aligned with the objectives and strategic plans of each business
  • Provide support and expertise to develop and supervise the execution of patient insight data collection methods, including Patient Perspective Input (PPI) and Patient-Centered Benefit/Risk (PCBR) study objectives, rationale, strategy, and methods
  • Author RFPs and evaluate proposals for patient insight studies requiring the use of external contractors
  • Act as a single point of contact for external contractors engaged in patient insight studies on behalf of Edwards
  • Manage external and internal patient insight studies against relevant stakeholder objectives and strategies to maintain Edwards’ quality standards
  • Ensure patient insight study progress to achieve milestones and business or regulatory deadlines
  • Develop and manage publication strategy
  • Produce metrics to track performance and success of patient insight data collection efforts
  • Advocate for patient-centric changes to healthcare systems:
  • Lead strategy to influence changes to healthcare systems to 
  • Appropriately consider patient perspectives in the regulatory approval and reimbursement process
  • Encourage the collection and utilization of data reflecting patient priorities in regulatory and reimbursement decision-making
  • Support an ecosystem that encourages collection of patient perspectives
  • Translate the experience and outcomes of Edwards’ patient insight initiatives to support the development of key public policies 
  • Contribute to the development of regulatory and legislative policy regarding the use of patient insight study data in regulatory policy development and decision-making 
  • Represent Edwards in relevant public policy development venues in support of this patient-centric advocacy strategy 
  • Develop coalition(s) of patient advocacy organizations to support and advance advocacy strategy, as appropriate
  • Regulatory/Agency Engagement Management:
  • Collaborate with the Vice President of Patient Engagement in coordinating global efforts to communicate patient insight study objectives, rationale, strategy, methods, results, and implications to regulatory (e.g., US FDA, EU MDD, JP MHLW) and reimbursement (e.g., US CMS, Ministries of Finance) agencies
  • Manage regulatory (USFDA) and reimbursement (CMS) agency engagement, and work directly with agency staff as needed to promote the use of patient insights in regulatory and reimbursement decisions
  • Create reports, presentations, and publications as needed to communicate patient insight activities

    Required Education/Skills/Experience:  

  • Masters of Public Health or equivalent degree in statistics, epidemiology, health economics or other relevant field
  • Minimum 8 years of experience in market research, observational research, epidemiology, health economics, clinical research, statistics or related field(s)
  • Minimum 5 years of experience in medical device or related industry
  • Experience in medical device or pharmaceutical/biomedical regulatory and/or reimbursement policy preferred
  • Must be able to work in a team environment, including inter-departmental teams 
  • Excellent project management and verbal and written communication skills
  • Ability to work independently and be self-directed
  • Proven ability to manage multi-disciplinary teams across remote locations
  • Willingness and availability to travel approximately 20% of the time
  • Ability to manage competing priorities in a fast paced environment
  • Ability to interact with senior internal and external people on significant matters often requiring coordination between organizations
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