Sr. Director - Global Regulatory Affairs - Product Communications Therapeutic Lead (Immunology) Join to apply for the Sr. Director - Global Regulatory Affairs - Product Communications Therapeutic Lead (Immunology) role at BioSpace Sr. Director - Global Regulatory Affairs - Product Communications Therapeutic Lead (Immunology) 2 days ago Be among the first 25 applicants Join to apply for the Sr. Director - Global Regulatory Affairs - Product Communications Therapeutic Lead (Immunology) role at BioSpace 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. Were looking for people who are determined to make life better for people around the world.

Purpose

The Sr. Director, GRA, Product Communications, is responsible for demonstrating regulatory leadership and influence in facilitating effective partnerships with assigned US Business Unit working along with other cross-functional leaders and alliance partners to consistently and efficiently develop and deliver accurate, balanced, substantiated product and disease information which enables informed decision making by our customers (patient, provider and payer). To effectively partner and support the needs of the US Business Unit, the Sr. Director will lead a team of regulatory personnel, providing administrative oversight and direct supervision. The Sr. Director must also develop mutually productive relationships with the FDA Office of Prescription Drug Promotion (OPDP), Lilly components and alliance partners in support of marketed product activities.

Additionally, the Sr. Director leads regulatory personnel during the internal strategy discussions, preparation and implementation of interactions with OPDP.

Primary Responsibilities

Staffing and People Development

Coaches staff to ensure

Compliance with all applicable regulations, internal policies and quality systems High quality, timely and decisive regulatory advice to allow business partners to make well-informed decisions Development of promotional materials that educate customers about the benefits and risks of Lilly products by introducing multiple alternative approaches that may meet the business objectives while maintaining compliance with applicable regulations and internal policies Support implementation of the Customer Information Quality (CIQ) system, including setting appropriate direction to staff on navigating development and approval of promotional tactics with review of product and disease state communications within the CIQ processes. Participates in performance management process for reporting staff members. Provides input into salary administration and promotion recommendations, talent assessment, and succession planning discussions for reporting staff members. Provides frequent reinforcement, coaching or feedback to staff. Actively supports staff to share any new learning. Participates in and promotes reward and recognition. Contributes to the development of others by mentoring and supporting individual staff member's career development with actionable development plans. Proactively recruits talented staff. Models the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. Provide coaching and oversight for contracted regulatory personnel supporting therapeutic area

Provide effective leadership and regulatory expertise to US Business Unit

Support implementation of the Customer Information Quality (CIQ) system, including timely completion of impact assessments for deviation management, input into change controls, and quality review of promotional material submissions to FDA. Attend US Business Unit meetings and participate actively in making recommendations regarding proposed promotional activity plans Develop relationships with personnel in other Lilly functional areas (i.e., marketing, medical, legal, labeling, compliance, quality etc.) to effectively influence the implementation of appropriate promotional messages Establish effective collaborative relationships with Regulatory leadership at alliance partner company(ies), as applicable Constructively challenge teams to reach the best solutions to issues. Demonstrate strong problem-solving skills and ability to address and effectively communicate complex regulatory issues Provide input into risk mitigation strategies to inform and influence business leaders by monitoring and communicating factors and trends in the external environment related to therapeutic area regulatory expertise and advertising and promotion topics from OPDP enforcement actions and Company learning across Business Units through interactions with FDA

Exercise accountability for knowledge transfer across GRA

Partnering with Therapeutic Directors from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising decisions Developing an understanding regarding the background of regulatory and marketing history of applicable products in all US Business Units Attending internal and external training programs, such as staff meetings, town halls, DIA, FDLI and RAPS meetings. Encourage staff to share lessons learned in forums such as GRA staff meetings

Lead/Influence/Partner

Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions Models the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. Regularly communicate across GRA components (e.g., labeling, central registration, regulatory intelligence) to facilitate sharing of information that allows the entire component to more effectively support development and commercial teams Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners Constructively challenge teams to reach the best solutions to issues Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions Serve as a mentor for GRA personnel

Minimum Qualification Requirements

Bachelor's Degree 10+ years experience in US Regulatory Advertising and Promotion Comprehensive knowledge of FDA procedures and practices across Review Divisions and OPDP (CFR guidelines, Guidances, etc.) Awareness of evolving regulatory reform initiatives and pending changes (Federal Register, media reports, etc.)

Additional Skills/Preferences

Knowledge of drug development process, regulatory/business strategies and plans Demonstrated ability to influence without authority Demonstrated ability to deliver complex projects against a timeline Strong communication skills (active listening, verbal, and written) Demonstrated ability to apply systematic thinking/mindset to business problems and opportunities Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

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), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$162,000 - $237,600

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 Lillys compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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