Associate Director, Solutions Consultant - Regulatory Affairs
Parexel International Corporation
USA - Any Region - Home Based
Great opportunity which combines your Regulatory Affairs, Regulatory Operations, or Quality Compliance expertise with your ability to identify opportunities and to present solutions to clients as they strive to move their products forward in the development process and present new treatment options to patients!
The Associate Director, Solution Consultant will be a recognized professional in the life science area (regulatory affairs, regulatory operations, or quality compliance), with experience in development of proposal pricing and service offerings or operational delivery of successful solutions. They work in partnership with the Commercial Organization and other Parexel business units to optimize new business awards through the development of compelling operational and technical strategies and business solutions to support current and future client needs.
• Work in partnership with colleagues in Commercial (Enterprise Accounts / Growth Accounts), Parexel Consulting Delivery and Marketing to support specific sales initiatives:
• Strategic guidance for major accounts
• Assist to identify and qualify new opportunities
• Craft creative solutions for specific sales campaigns
• Drive content to assist in early engagement
• Participate as a member of the discovery sessions to understand the client's business objectives and support clients through pre-award process, as required
• Create a strong “outside-in”/One Parexel culture and drive a consultative approach which enables Parexel to develop unique business solutions for its customers and positions the value of those solutions to drive industry leadership
Solutions Development (Parexel Consulting – Regulatory)
• Lead the solution development team and proactively engage with experts across Parexel to create bespoke regulatory solutions that maximize value for the customer and differentiate Parexel from its competitors
• Drive the development of efficient, competitive and profitable solutions, scope and budgets
• Ensure milestones, scope and hours budgeted are achievable
• Ensure appropriate assumptions are included in proposals/work orders
• Maximize Parexel's ability to capture Change in Scope (CIS) through effective risk assessments and clarity of terms
• Maintain extensive knowledge of relevant products and pipelines and identify business opportunities for Parexel
• Maintain extensive knowledge of competitors, industry trends and innovations to best position Parexel to win new business
• Support the development of customer focused, well presented regulatory proposal content and budgets that clearly differentiates Parexel from its competitors and helps to drive growth of Parexel business across SBUs
• Ensure client responses reflect strategy discussions, meet client needs, offers consistent messaging, conveys value proposition and critical success factors
• Define bid pursuit content; review and integrate content and considerations into Bid strategy as required
• Support/participate in bid pursuit meetings as needed
• Solution Adoption & Delivery
• Ensure effective handover and subsequent adoption of solution to SBU Delivery
• Maintain efficient knowledge of solution delivery. Liaise, as required, with delivery oversight to ensure solution sold meets expectations of time, cost, quality and customer satisfaction. QualificationsSkills:
• Demonstrates an energetic, 'make it happen' attitude, capable of thriving in a complex matrix environment with an ability to build strong cross functional relationships.
• Strong understanding of commercial ecosystem and awareness of industry trends in their area of expertise through active participation in leading industry forums and professional organizations as well as maintaining awareness of relevant changes in global regulations.
• Ability to see the strategic view while employing pragmatic approaches to delivery
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
• Demonstrated ability to communicate complex ideas in a simple, understandable and compelling manner
• Willing to travel up to 30%
Knowledge and Experience:
• Several years (5-7) of relevant experience in a full service CRO (with focus on regulatory) or regulatory consultancy is required
• Experience in strategic drug development planning
• Some commercial exposure with supporting service proposals and pricing activities
Bachelor’s degree, with concentration in life sciences or healthcare-related field preferred. Advanced degree preferred.
Willingness to travel up to 30% may be required
Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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