Associate Director - GRA, Global Regulatory Policy & Strategy

Role Summary

Global Regulatory Policy & Strategy identifies policy hurdles and emerging trends, develops science-based policy positions, and engages broad partner networks to influence regulatory policies that improve patient outcomes and the efficiency of drug development. The Associate Director – Global Regulatory Policy & Strategy will support multiple U.S. regulatory policy campaigns by building Lilly policy positions, assessing external stakeholder groups, and representing Lilly on relevant external work groups to effect policy change.

Responsibilities

• Lead the development of Lilly policy positions in coordination with internal subject matter experts (i.e., problem statements and desired future state)
• Collect data and/or conduct research to support company policy positions
• Perform stakeholder analyses to understand external perspectives on key Lilly policy priorities
• Track, monitor, and provide analysis of relevant regulatory policies, as advised by management
• Monitor the external environment for new regulatory and policy developments and possible implications for Lilly’s positions and connect with internal stakeholders
• Develop and implement tactical policy plans, including a description of both short- and long-term project deliverables
• Contribute to the development and execution of global regulatory policy strategies that align with Lilly’s long-term business objectives and external policy landscape
• Develop relationships with key external stakeholders to understand their perspectives and advise them regarding Lilly’s positions
• Represent Lilly in external forums, including regulatory agency meetings, trade associations, and policy roundtables
• Impact patient outcomes through collaboration across partner groups
• Exemplify Team Lilly behaviors in internal and external interactions
• Model innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers
• Engage in forums that share regulatory information across GRA components and other Lilly teams and business partners

Qualifications

• Required: Bachelor's Degree in policy, public health, regulatory, clinical, legal, business, research, science or related field
• Required: 2+ years prior regulatory/policy experience
• Required: Authorized to work in the United States on a full-time basis; Lilly will not provide support for or sponsor work authorization or visas for this role
• Preferred: Masters, doctorate or advanced degree is preferred
• Preferred: 3+ years of regulatory/policy experience is preferred

Skills

• Strong interpersonal skills and demonstrated ability to manage external and internal relationships with key stakeholders
• Ability to research and write briefings, positions, and high-level communication
• Independence, resourcefulness, and ability to influence without authority
• Strong verbal and written communication

Education

• Bachelor's Degree in policy, public health, regulatory, clinical, legal, business, research, science or related field
• Masters, doctorate or advanced degree is preferred

Additional Requirements

• Travel up to 25%
• This position is based in Lilly's Washington, DC office or Remote