The Director, Consulting Expert, Life Sciences Regulatory Operations will be a lead in driving the development of the R&D Practice group and will be the lead for Regulatory Operations. This individual will have a unique opportunity to support practice development, establishing thought leadership and providing support during strategic sale pursuits and initiatives for top-tier pharmaceutical, biotech and med device clients from conception through successful implementation and on-going support. This highly-visible position will work with clients on both the business and IT teams to define, plan and execute strategic initiatives that will improve operational performance, increase profitability and create a competitive advantage. This team member will lead initiatives across a variety of topic areas within the Regulatory space of life sciences, including Regulatory operations, trial start-up and management, Regulatory systems (implementation through use, etc), and data management related topics We are looking for someone with the desire to drive innovation in the industry by partnering with clients and partners to disrupt the current state of life sciences or healthcare. This position will also be instrumental in building new capabilities and developing innovative ways for CGI to help its clients transform and grow.
• Develop and support client relationship and business development activities
• Define and develop Life Science core framework assets
• Support, as an SME, client adoption of core framework engagements
• Support marketing campaign efforts
• Improve quality of services, support colleagues and propagate knowledge and expertise
• Leverage engagement deliverables and project management experiences to form the basis of re-usable approaches and methodologies
• Understand the pharmaceutical environment and anticipate client needs/market evolution.
• Lead and support development of market-leading capabilities related to area of expertise to support current and future needs within our Life Sciences clients
• Help business stakeholders envision necessary transformation and how their work will need to change to support the future.
• Serve as the bridge between the business and IT stakeholders to embrace technology as a tool to solve business problems.
• Support and guide clients to define, develop and plan various consulting engagements from short-term assessment projects to large-scale transformational initiatives.
• Define business needs and analyze complex problems. This includes but is not limited to scoping, requirements development, process development, communications, planning for individual efforts.
• Identify and document the needs of multiple stakeholders.
• Identify the current- and future-state business processes.
• Facilitate workshops and brainstorming sessions with various client stakeholders and teams to identify key business challenges and define potential solutions and/or initiatives.
• Foster partnership with customers, stakeholders, sponsors.
• Build and maintain strong client relationships and develop business with assigned clients.
• Build and lead teams to foster individual and team development and expertise.
• Leverage CGI Operations Management standards to achieve targeted revenue and profitability.
• 10+ years Regulatory experience in the pharmaceutical, biotech and/or med device experience is required.
• Must have a strong understanding of life sciences Regulatory capabilities, business strategies, sales and marketing principles and Regulatory operations.
• Understanding of technologies and solutions utilized in the market access space, particularing contract management
• Experience in Regulatory systems and processes is required.
• Experience driving multi-functional and multi-company teams is required. Program governance establishment and management requiredBachelor’s degree in business, engineering or sciences. MBA or other advanced degree is a highly desired
• A minimum of 5-7 years’ experience in management consulting or the pharmaceutical Regulatory industry. Management consulting experienced is highly desired.
• Passion for emerging digital trends influencing the pharmaceutical Regulatory business
• A history of leading and supporting successful projects.
• General knowledge of hardware and software technologies.
• Competency in Microsoft applications including Word, Excel, PowerPoint, MS Project, Visio.
• Strong experience with technology and IT organizations is important.
• Global experience is desired, but not required.
• Lives up to the CGI Values: Partnership and Quality, Objectivity and Integrity, Entrepreneurship and Sharing, Respect, Financial Strength, Corporate Social Responsibility
• Demonstrates leadership: cultivates team spirit, provides direction and vision, displays integrity in action, fosters open communication
• Self-motivated with the ability to effectively multitask in a fast-paced environment.
• Knowledge of business development and sales tools and techniques
• Ability to provide outstanding customer service, be a good listener and work well with others.
• Relevant project management delivery tools and techniques
• Analytical, problem solving, and conceptual thinking skills.
• Organizational and time management skills.
• Excellent meeting planning and facilitation skills.
• Excellent documentation skills.
• Excellent written, verbal communication and negotiating skills, with customers, team and stakeholders
• Ability to influence stakeholders and work closely with them to determine acceptable future state solutions.
• Ability to understand the workflow and business processes related to the application being supported.
• Ability to effectively interface with technical and nontechnical staff at all organizational levels.
• Ability to learn new content areas and new skills quickly.
• Outstanding attention to detail
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It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this change—supporting our clients’ digital journeys and offering our professionals exciting career opportunities.
At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.
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