The opportunity
We’re looking for Associate Director with expertise in Life Sciences Regulatory Compliance and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.
Your key responsibilities
Client Responsibilities
- Participate and lead Regulatory Compliance engagements
- Help manage the financial aspects of engagements by organizing staffing, tracking fees, and communicating issues to project leaders
- Drive-in business development initiatives along with client management and account management
- Build strong internal relationships within Risk Consulting practice and with other services across the organization
- Build connect with client stakeholders, understand their business challenges / pain areas and work with leadership to propose innovative solutions
People Responsibilities
Develop people through effective coaching and mentoringConduct performance reviews and contribute to performance feedbackContribute to people-related initiatives including recruiting, retaining, appraisal and trainingContribute towards building and strengthening team competency for Regulatory Compliance and Risk consultingParticipate in the organization-wide people initiativesMaintain an educational program to develop skills of team members continuallyDecision-Making Responsibilities :
Support management in workforce planning, resourcing strategy, go to market strategy and demand generationUnderstand the business requirements clearly and lead practice development initiatives as requiredBring out of the box thinking mindset, and analytical thinking capability to enhance service deliveryAlways maintain connections with clients to tap opportunities for constant growth and improvementUnderstand the process gaps and propose preventive / corrective action where appropriateLead business growth, pursuits and client proposals for Enterprise Risk / Regulatory Compliance, directly working with the regional partners and Associate Directors.Other Responsibilities
Actively contribute to the IT applications project management initiatives that includes Validation / Qualification / Variance Management activities as per GAMP Life Cycle approachIntegrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagementIdentify opportunities in existing accounts to cross-sell other EY services.Planning and monitoring of the project deliverables from the team.Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelinesMaintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements / standards relevant to the client's business.Regular status reporting to the Associate Directors, Partners, Directors and onsite coordinators.Actively contribute to improving operational efficiency on projects & internal initiatives.Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.Demonstrate flexibility to travel to the customer locations on need basisConduct performance reviews and contribute to performance feedback for staff, senior and managersFoster teamwork, quality culture and lead by exampleUnderstand and follow workplace policies and proceduresTraining and mentoring of project resourcesParticipate in the organization-wide initiativesLead practice initiatives and portfoliosMarket trend +Digital trends.Cross skill and cross train the team members as per the business requirementsSkills and attributes for success
Quality & Compliance managed services and Consulting experience in of Life Sciences Domain.Sound domain knowledge in Pharmaceutical industry in the areas of Quality and Compliance