Senior Director, GRA Global Regulatory Policy & Strategy - Neuroscience

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Global Regulatory Policy & Strategy strives to enable Lilly to deliver innovative regulatory results by identifying policy hurdles and emerging trends, developing advocacy plans built upon science-based positions, engaging broad partner networks, and ultimately effecting change in regulatory policies that advance patient outcomes, reduce regulatory risk, and improve efficiency in drug development. The purpose of the Senior Director – Global Regulatory Affairs (GRA) Global Regulatory Policy & Strategy - Neuroscience role is to elicit, develop, and progress Lilly’s Neuroscience regulatory policy positions and related advocacy strategies to enable innovation and ultimately improve outcomes for patients. In this role, you will represent Lilly in external consortia and policy-related forums and rely on a strong pre-existing network of external collaborators.

Primary Responsibilities:

Establish Regulatory Policy Positions and External Engagement Strategies:

• Gain consensus on Lilly’s priority global regulatory topics consistent with GRA’s overall regulatory policy vision, which will center around topics that encourage innovation in drug development and regulatory review of medicines targeting various types of neurological disease and pain.
• Critically review and analyze regulatory and legislative proposals and identify possible policy, political, and financial impact to Lilly in cooperation with cross-functional partners
• Articulate regulatory policy challenges, problem statements and desired future states.
• Identify and develop data and evidence to support company positions, working in collaboration with cross-functional colleagues.
• Bring in or represent external viewpoints as company positions are developed.
• Cultivate relationships and collaborate with internal subject matter authorities, including Neuroscience colleagues and regulatory team members, among others, to create evidence and positions.
• Build and implement tactical policy plan.

Exert External Influence:

• Engage on behalf of Lilly in health-policy related forums.
• Triage opportunities to engage externally so that the appropriate company experts can contribute.
• Attend and present at key industry conferences to showcase Lilly policy positions.
• Build upon existing relationships and maintain strong collaborations with external patient/professional groups, think-tanks, academic groups, policy organizations and trade associations.
• Impact patient outcomes through collaboration across partner groups

Effectively lead, engage and partner:

• Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions.
• Model the 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.
• Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions.

Minimum Qualification Requirements:

• Master's degree or Doctorate in relevant policy, public health, regulatory, clinical, legal, business, research, or related field with 5+ years regulatory/policy/advocacy experience OR
• Bachelor’s degree with 10+ years regulatory/policy/advocacy experience
• Qualified applicants must be 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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills and Preferences:

• Experience engaging in external consortia and passionate about crafting policy issues.
• Recognized experience in leading/implementing public policy or regulatory policy campaigns.
• Established external network in subject matter area of focus (neuroscience)
• Previous experience shaping regulatory policy issues related to neuroscience
• Prior work with relevant patient and provider organizations
• Proficient in researching and writing briefings, positions, and high-level communications for executive staffing.
• Ability to influence without authority, demonstrate resourcefulness, and operate independently

Additional Information:

• Travel up to 20%
• Position Location: Preference for Indianapolis, IN or Washington DC, will consider Remote (US)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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