About the position
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.
Responsibilities
- Coaches staff to ensure compliance with all applicable regulations, internal policies and quality systems.
- Provides high quality, timely and decisive regulatory advice to allow business partners to make well-informed decisions.
- Develops promotional materials that educate customers about the benefits and risks of Lilly products.
- Supports implementation of the Customer Information Quality (CIQ) system, including setting appropriate direction to staff on navigating development and approval of promotional tactics.
- Participates in performance management process for reporting staff members.
- Provides frequent reinforcement, coaching or feedback to staff.
- Contributes to the development of others by mentoring and supporting individual staff member's career development.
- Proactively recruits talented staff.
- Models the innovation and leadership behaviors and regulatory excellence attributes.
- Provides coaching and oversight for contracted regulatory personnel supporting therapeutic area.
- Supports implementation of the Customer Information Quality (CIQ) system, including timely completion of impact assessments.
- Attends US Business Unit meetings and participates actively in making recommendations regarding proposed promotional activity plans.
- Develops relationships with personnel in other Lilly functional areas to effectively influence the implementation of appropriate promotional messages.
- Establishes effective collaborative relationships with Regulatory leadership at alliance partner company(ies).
- Constructively challenges teams to reach the best solutions to issues.
- Provides input into risk mitigation strategies to inform and influence business leaders.
- Partners with Therapeutic Directors from GRA to consider FDA Review Division perspectives.
- Encourages staff to share lessons learned in forums such as GRA staff meetings.
- Exemplifies Team Lilly behaviors in internal and external interactions.
- Regularly communicates across GRA components to facilitate sharing of information.
- Participates in forums that share regulatory information across GRA components and other Lilly teams.
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.
- Awareness of evolving regulatory reform initiatives and pending changes.
Nice-to-haves
- 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.
Benefits
- 401(k)
- Pension
- Vacation benefits
- 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
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
