Associate Safety Project Director
- Experience Level
- Senior Management
Provide strategic leadership at customer (or strategic) account level for large post-marketing, clinical trial or combination programs or customer accounts, as assigned by senior management team. Act as a senior level point of contact throughout project duration for local and globally scoped deliverables with single/multiple Lifecycle Safety functions. Collaborate with global management team and integrated partners to develop and implement strategic initiatives / solutions and ensure global consistency.
- Manage customer interface and communication for large programs or standalone projects. Represent Lifecycle Safety on projects/programs; serve as primary point of contact within Lifecycle Safety for all internal and external customers; liaise between internal/external customers and Lifecycle Safety Operational teams.
- Manage customer deliverables for assigned projects/programs. Tactical, day-to-day customer-facing leadership at project/program level. Responsibilities include project planning (timelines, deliverables), scope management, quality management and project financial management.
- Act as an account owner over a program or customer portfolio and therefore report program/portfolio level metrics and provide oversight of projects they do not directly lead.
- Performs role of solution architect responsible for crafting and defending proposed solutions to new standalone Safety business opportunities. Formulates operational budgetary assumptions and takes decisions to steer the creation of the budget, fulfill required customization of text and data. Acts autonomously as the Safety Subject Matter Expert (SME) and single point of contact for Governance, Executives and Integrated Partners in construction of proposed solution and defends the strategy and pricing from initiation through to delivery.
- Represents as Safety SME. Provide leadership and accountability for customer-facing collateral and operational support to deliver key customer messages, working cross-functionally and across the opportunity lifecycle, integrating lifecycle safety core message delivery into customer facing material, presentations and meetings. Collaborate with senior leadership to implement strategic initiatives and ensure global consistency.
- Provide leadership structure for customer service interface from scoping stage, through proposal generation, bid defence to transition of work and service delivery; and throughout the development and commercial life cycle of the product.
- Attend Joint Operating Committee Meetings and / or Governance meetings to provide portfolio level quality and compliance metrics, to provide other portfolio level updates, and to partner with customers at a Senior Management Level.
- Lead internal escalation meetings to ensure quick response to any quality concerns or customer escalations, ensuring appropriate representatives from stakeholders and operational management are involved as appropriate.
- Manage finances for assigned projects/programs. Update financial systems, revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc.
- Ensure financial project performance through oversight of key performance metrics (i.e. revenue, direct costs, time-sheet costs, contribution margin).
- Develop specialized expertise across the Pharmacovigilance spectrum (e.g. Global Regulatory, Regulatory reporting requirements), and apply this expertise within assigned projects, and cascade knowledge to PV Solutions team as appropriate.
- Work with sales and proposals to ensure rapid, seamless, tailored responses to opportunities. Drive business growth by improving customer loyalty through enhanced customer relations, service delivery excellence and excellent customer communication.
- Manage start-up of new projects using standard operating procedures and best practices, including identifying potential risks during project initiation and implementing mitigation measures to ensure seamless delivery at maintenance stage.
- Lead meetings with internal and external stakeholders. Provide project status updates, defines processes, project/planning strategy.
- Provide leadership for Lifecycle Safety virtual project teams: keep local/global Lifecycle Safety team current on project developments; lead internal Lifecycle Safety team meetings to review project processes and status. Work closely with Lifecycle Safety Operational teams, to ensure projects/programs are delivered in accordance with customer expectations.
- Facilitate sales activities, and sales presentations (capabilities, bid defenses) and proposal development (strategy, costs and text), as needed.
- Incorporate strategic options when defining project/program scope and processes with customer.
- Develop customer relationships into partnerships; manage accounts targeting extended business relationship throughout lifecycle. Focus on customer loyalty and contract renewal. Facilitate discussions on new business opportunities with existing customers.
- Work in a customer centric fashion analyzing current and future customer needs and actively developing innovative, cross- functional strategic solutions within Lifecycle Safety service lines to meet customer needs.
- Actively contribute during client and internal audits and inspections for assigned project. Liaise with Quality Assurance staff and management in the compilation of corrective action plans.
- Identify and drive departmental initiatives aimed at enhancing customer service, efficiency, quality, or employee engagement.
- Represent LS Leadership at select external and internal meetings.
- Takes on a higher level of leadership within the department to mentor and support junior leads.
- Collaborate with Lifecycle Safety Management to resolve problem areas and customer needs ensuring global consistency.
- Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- 6 to 7 years' clinical research experience in a Contract Research Organization or Pharmaceutical company combining 6 years of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc.) and 3 years' project management experience