FUNCTION: Regulatory Affairs Business Operations – RA Human Capital
POSITION OVERVIEW:
This role reports into the head of RA Human Capital which sits within RA Business Operations. RA Business Operations is key group within the broader global Regulatory Affairs organization and is a strategic partner and advisor to other Regulatory Affairs functions and teams and their partners and stakeholders. RA Business Operations helps ensure that the worldwide Regulatory Affairs organization operates with the highest standards of quality, efficiency and compliance, while further supporting strategic decision-making and continuous improvement. RA Business Operations provides a broad range of expertise and services such as: operational excellence, best practices, knowledge management, business process and continuous improvement, performance metric setting and reporting, quality and compliance monitoring and reporting, vendor and resource management, training and education for RA colleagues and their partners and stakeholders, and more.
In this role, 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 the data that enable strategic decision-making regarding headcount utilization and needs at an organizational level. You will be responsible for the overall influence and impact of the resource management capability. You will play a highly influential role, in partnership with the Regulatory Affairs Leadership Team, in the workforce planning process to maintain appropriate headcount levels and skillsets across Regulatory Affairs in alignment to the demand and financial plan. You enjoy working with people at all levels and complex datasets. You have an expert understanding of the 3 pillars of resource management (named resourcing, resource forecasting, and strategic workforce planning).
By aligning talent to strategic priorities, this role enables the organization to meet critical submission deadlines, maintain compliance, and ensure a future ready workforce. This role is highly collaborative reflecting the way in which our resourcing reality is also tied to vendors, technology, process, performance excellence, cross-functional governance, and other capabilities. We seek to not just identify resource constraints but to creatively solve for them.
As part of the RA Business Operations extended leadership team you will have the opportunity to support across disciplines and help build an integrated suite of Centers of Excellence.
You may manage a team of direct reports and may have indirect reports, with responsibility to lead other people managers. You will routinely represent RA Business Operations to a wide variety of stakeholders and partners, including within and outside of RA. You will routinely lead special projects. You will have a systems-thinking mindset, a passion for operational excellence, and the ability to drive cross-functional collaboration.
EXAMPLE RESPONSIBILITIES:
- Own the data quality, infrastructure, and business practices related to resource management.
- Leads special projects and pilots that advance the capabilities of RA Business Operations.
- Provide support across Business Operations capabilities as needed (Vendor Management, Business Process Excellence, Inspection Readiness, Business Process Excellence, Change Management, Communications and Engagement)
- Makes significant contributions to short- and long-range RA strategies, plans, and infrastructure development, and Development, RSQ and RA-wide initiatives and evolutions.
- Collaborate within Human Capital (Resource Management and Vendor Management) to drive holistic internal/external resourcing strategies across RA
- Embed resource management concepts and influence the culture and practices across RA as it pertains to managing demand, increasing capacity, developing talent in line with strategy, and creative solutioning.
- Build relationships and trust with a network of leaders and sub-functional spoke contacts to influence and deliver the goals of resource management and Business Operations
- Manage difficult conversations including headcount discussions, prioritization, and interrogation of data quality
- Lead yearly Strategic Workforce Planning cycles in partnership with Head of Human Capital. Track and drive changes to address gaps identified in workforce.
- Oversee the maintenance of algorithmic forecasting (Planisware) in collaboration with others on 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 our portfolio.
- Aligns resource data and planning efforts to facilitate decision-making forums, including capacity planning and initiative review meetings.
- Provides guidance and recommendations, based on data, of the future resource needs for latest estimate/year end processes, etc. for Regulatory Affairs functional areas as needed. This role is the consultant to the business on all things resourcing related.
- Partners with the Regulatory Affairs Leadership Team to develop mitigation plans to address gaps in demand and capacity in collaboration with the Human Capital Lead and Vendor Governance.
- Provides 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 Performance Excellence Infrastructure Lead
- Continual improvement and maturation of Resource Management capability
- Develop performance and resource management guidelines and training materials for team leads and project managers.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education:
- MA / MS / MPH with 10+ years of Regulatory Affairs, resource and/or project management OR 8+ years with a PhD with relevant experience OR a BA / BS with 12+ years Regulatory Affairs, resource and/or project management.
- Experience managing complex projects and implementations.
- Planisware, Smartsheet (including Resource Manager, Control Center), or other named resourcing experience required.
- Knowledge of resourcing and forecasting methods and applicable tools for tracking and forecasting needs.
- Preferred candidates will demonstrate relevant cross-Business Operations skillsets beyond Resource Management including Performance Management, Business Process Excellence, Change Management, Communications and Engagement, etc.
- Experience creating insightful reports, presentations, and forecasts that allow for 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 to important milestones while maintaining a positive, transparent, and collaborative team environment.
- Ability to establish priorities, operate with a sense of urgency and collaborate (interpersonal, relationship management) 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.
People Leader Accountabilities :
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach themoncurrent performance and future potential. They ensure employees are receivingthe feedbackand insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
