Global Regulatory Affairs Planning, Capacity Management, Metrics Lead – Contract
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
- The Planning, Capacity Management, Metrics Lead integrates Global Regulatory Affairs (GRA) portfolio planning for Research and Development (R&D) projects, and automated planning of submission milestones of lifecycle maintenance activities, with resource capacity management of headcount to provide accurate metrics.
- The major results are best utilization of plan information for decision making, and to have efficient management of resources.
- The incumbent uses R&D and GRA planning tools to plan growth driver activities and creates strategic resource scenario forecasts for the GRA Leadership Team to allocate resources within budget.
Key Accountabilities of the Planning, Capacity Management, Metrics Lead are:
GRA Workload Resource Capacity Planning
- Evolve workload, demand, planning and capacity management models and analysis for GRA globally including (Global Business Units (vaccine, specialty care, general medicine), Team Leads , CMC, labelling, operations, regions)
- Deploy GRA R&D project resource algorithm for priority projects and then scale up modelling to other key priority projects
- Lead meetings with Global Regulatory Teams to assess resource capacity on priority projects, identify resource risks vs. available capacity, and finalize recommendation for budget and resource allocation
- Define and manage the process of resource data collection and monitoring accuracy with a network of resource managers within GRA Units
- Evolve, maintain, improve Resource Management File (RMF), and activity profiles in order to provide accurate and up to date internal capacity and activity metrics and support productivity unitary calculations
- Develop a more robust process for estimating external capacity to support GRA decision making
- Propose efficiency gains for internal and external resources
GRA R&D Planning
- Plan GRA deliverables for products or R&D projects under delegated responsibility
- Drive the RA project planning process using R&D tools and GRA templates, and optimize use of plan information to provide progress reports allowing GRA to prioritize activities and monitor compliance
- Collaborates with Global Regulatory Team and other functions (PV, Epidemiology) as well as with R&D Project Manager, Clinical Manager, Industrial Project Manager and Com Ops Project Manager to define, improve and operationally manage the regulatory functional plans and ensure alignment, acceleration, and integration with overall R&D plans
Subject Matter Expert (SME) for the Qlik Sense Regulatory Portfolio Portal Capacity & Activity (C&A) app, Demand forecast model, and R&D Planisware GRA Planning templates
- Develop working instruction, and outline learning and required competency plan for different stakeholders. i.e. GRA (leadership user, manager, delegate for data source RMF, CRO file) who use the RMF/C&A app
- Contribute to the development, testing, implementation and maintenance lifecycle of new planning and resource capacity tools and services
- Gather requirements for innovating these planning and workload resource capacity systems, templates, working instruction and reports
- Define business requirements and recommend a technical approach to meet those needs
- Prepare documentation (release notes, user guide) surrounding the deployment of new features to ensure effective use and support
Education / experience:
- BSc in Health/Life Sciences, Pharm D, Medical, Biological Science Engineer
- Regulatory professional in pharmaceuticals, vaccines, health care industry (3+ years)
- Planning and Project Management (5+ years)
- Resource capacity management, metrics, finance, budget, procurement
- LEAN process improvement and change management
Major skills and competencies:
- Resource capacity management best practices
- Expertise in planning tools (Planisware), MS Project, Teams Planning Application Excel and analytical tools (Tableau, Qlik),
- Good interpersonal, communication (verbal and written), and negotiation skills to synthesize, and challenge resource projection models
- Fluent in English both spoken and written, French is strong asset
- Strong project management skills:
- Anticipates problems, issues, and delays, and proactively works to minimize the impact
- Learns quickly when facing new problems
- Uses rigorous, objective logic and methods to solve difficult problems with effective solutions
- Ability to analyze data and report metrics to monitor trends in a visually impactful way
- Influence and lead without authority
- Develop strategic recommendations beyond a team of GRA professionals, and think on an organizational level to create optimized acceleration of R&D Projects and required resourcing
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Sanofi, Empowering Life
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
To Apply, Click Here: http://bit.ly/38aRzLv
Reference No: R2572258
Location: Toronto, Canada
Contract end date: 2022/02/28
Sanofi Pasteur: The world’s leading vaccine company