Role Overview
This role reports into the head of RA Human Capital within RA Business Operations, a key group in the global Regulatory Affairs organization. Your work will help ensure that the worldwide Regulatory Affairs organization operates with the highest standards of quality, efficiency, and compliance while supporting strategic decision‑making and continuous improvement.
In this position you will be accountable for the end‑to‑end resource management capability for Regulatory Affairs. You will provide accurate and timely insights and resource recommendations based on data that enable strategic decision‑making regarding headcount utilization and needs at an organizational level. You will influence and impact the workforce planning process to maintain appropriate headcount levels and skillsets across Regulatory Affairs in alignment with demand and the financial plan.
Responsibilities
- Own the data quality, infrastructure, and business practices related to resource management.
- Lead special projects and pilots that advance the capabilities of RA Business Operations.
- Provide support across Business Operations capabilities as needed, including Vendor Management, Business Process Excellence, Inspection Readiness, Change Management, and Communications and Engagement.
- Contribute to short‑ and long‑range RA strategies, plans, and infrastructure development, and to RSQ and RA‑wide initiatives and evolutions.
- Collaborate within Human Capital to drive holistic internal/external resourcing strategies across RA.
- Build relationships and trust with a network of leaders and sub‑functional contacts to influence and deliver resource management goals.
- Manage difficult conversations, including headcount discussions, prioritization, and interrogation of data quality.
- Lead yearly Strategic Workforce Planning cycles in partnership with the Head of Human Capital.
- Track and drive changes to address gaps identified in workforce planning.
- Oversee the maintenance of algorithmic forecasting (Planisware) in collaboration with the Human Capital team to improve algorithm accuracy and leadership understanding of resource trends.
- Orchestrate across RA leadership, Finance (LE cycles) and HR to enable the workforce needed to drive the portfolio.
- Align resource data and planning efforts to facilitate decision‑making forums, including capacity planning and initiative review meetings.
- Provide guidance and recommendations, based on data, for future resource needs for the latest estimate/year‑end processes across Regulatory Affairs functional areas.
- Partner with the Regulatory Affairs Leadership Team to develop mitigation plans addressing gaps in demand and capacity, in collaboration with the Human Capital Lead and Vendor Governance.
- Provide formal and informal training of resource concepts, processes, tools, and reports.
- Oversee technical administration of Planisware and Smartsheet Resource Manager tools in collaboration with Human Capital team members and the Performance Excellence Infrastructure Lead.
- Drive continual improvement and maturation of the Resource Management capability.
- Develop performance and resource management guidelines and training materials for team leads and project managers.
- Manage a team of direct reports with possible indirect reports and lead other people managers as required.
- Represent RA Business Operations to a wide variety of stakeholders and partners, within and outside of RA.
- Lead special projects and initiatives across multiple functions.
- Travel as needed for strategic and operational activities.
Qualifications
- MA / MS / MPH / PharmD / PhD with 8+ years in Regulatory Affairs, resource and/or project management.
- BA / BS with 10+ years in Regulatory Affairs, resource and/or project management.
- Experience managing complex projects and implementations.
- Experience with Planisware, Smartsheet (including Resource Manager, Control Center), or other named resourcing platforms.
- Knowledge of resourcing and forecasting methods and applicable tools for tracking and forecasting needs.
- Preferred: cross‑Business Operations skillsets beyond Resource Management, including Performance Management, Business Process Excellence, Change Management, Communications and Engagement.
- Experience creating insightful reports, presentations, and forecasts that enable actionable, strategic decision‑making.
- Strong understanding of the research and drug development life cycle processes, roles and systems required.
- Ability to influence and drive decisions without direct authority.
- Demonstrated negotiation, problem‑solving, critical thinking, and facilitation skills.
- Strong quantitative reasoning and analytical ability.
- History of motivating others with a positive attitude to deliver on important milestones while maintaining a transparent and collaborative team environment.
- Ability to establish priorities, operate with a sense of urgency, and collaborate with cross‑functional team members.
- Ability to proactively gather, interpret and evaluate information from a variety of resources to make decisions and recommendations.
- Proven ability to multitask in order of priority in a deadline‑driven environment with optimal efficiency and accuracy.
- Ability to communicate in a clear and concise manner.
- Ability to support a team‑oriented, highly matrixed environment.
- Ability to execute multiple tasks as assigned.
- When needed, ability to travel.
Legal Information
This position is subject to Gilead Sciences’ equal employment opportunity and affirmative action policies. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability, veteran status, or any other legal protected characteristic.
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