Risk Management Project Lead

Primary Responsibilities

• In collaboration with RAM Head, develops/evolves/implements best practices in risk management planning, including risk communication, risk minimization and in benefit/risk assessment methodologies.
  
  Manager RMPL
  
• With oversight, supports SSRM with strategic guidance for risk management planning, taking into consideration local regulatory requirements, risk management best practices, and product specific risk profile, and development and implementation of RMP initiatives for products within the client portfolio.
  
• Serves as the key interface between RAM and the BU in matters related to oversight of implementation and tracking of commitments included within the RMP and provide periodic updates regarding the status of implementation to the RMC
  
• Leads PRMS using effective leadership and process management techniques. Builds appropriate agendas, provides draft and final minutes and drives the actions to completion. Responsible for the storage and tracking of action items from meetings. Ensures appropriate membership attendance for internal and external meetings, including external expert engagement and briefing.
  
• Manages supplier performance/delivery relative to defined and agreed upon SOW; support managing day-to-day supplier communications.
  
• Provides regular reporting on all aspects of RMP milestones/performance per specific targets as defined by key performance indicators (KPIs) and/or regulatory commitments through maintenance and presentation of project performance dashboards.
  
• With oversight, creates/maintains project planning and execution documentation including, but not limited to, project charters, detailed project plans/milestones, progress reports, activity logs and deliverables, i.e. RMP submissions.
  
• Updates/maintains assigned project related documentation as per defined in risk management processes and file structure on designated system.
  
  Senior Manager RMPL
  
• In addition to the responsibilities listed above a Manager RMPL will be required to engage in the following activities and demonstrate the above and following qualities in a leadership capacity:
  Supports SSRM with strategic guidance for risk management planning, taking into consideration local regulatory requirements, risk management best practices, and product specific risk profile, and development and implementation of RMP initiatives for products within the client portfolio
  
• Creates/maintains project planning and execution documentation including, but not limited to, project charters, detailed project plans/milestones, progress reports, activity logs and deliverables, i.e. RMP submissions.
  
• Provides risk management education to internal and external colleagues
  
• With oversight, participates in audits and inspections; preparing and coordinating responses; participates in inspection readiness.
  
  Director RMPL
  
• In addition to the responsibilities listed above a Director (level 15) RMPL will be required to engage in the following activities and demonstrate the above and following qualities in a leadership capacity:
  
• Acts as a SME or BPO for a Safety SOP.
  
• Manages special projects and assists with communications.
  
• Provides guidance and coaching to less experienced RMPLs, participates in initial training of newly hired RMPLs, acts as first point of contact to assist other RMPLs in issue resolution.
  
• Has the foresight and judgement to recommend and then manage external safety KOL consultations, expert working groups, and other external safety forums.
  
• Implements opportunities identified for consistency and standardization in Safety
  
• Identifies and evaluates issues and presents strategies to ensure that timelines are met or accelerated.
  
• Influences above country and local individuals responsible for Safety, Regulatory, and Medical for appropriate risk management development and implementation
  
  Technical Skill Requirements
  
• High level analytical skills - Detail oriented, independent, and manage processes to both establish timelines and ensure timelines are met. Excellent organizational skills.
  
• Strategic Thinking - Demonstrated ability to analyze, frame, and communicate complex issues, including writing and presentation proficiency.
  
• Clinical, Regulatory and Safety Expertise - Demonstrated knowledge of clinical research processes, safety or regulatory requirements. Knowledge of Risk Management regulations and drug development process
  
• Technical Expertise - Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line.
  
• Scientific/Administrative Excellence - Demonstrated ability to scientifically evaluate and document review and analysis of data.
  
• Organizational Development - Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies.
  Project and Process Management & Meeting Established Deadlines - Demonstrated ability to manage multiple complex projects and cross-functional processes and to meet established deadlines. Experience in budgetary management.
  
• Computer applications - MS Word, Excel, PowerPoint presentations, etc., as well as department systems.
  
• Skills in matrix partnerships to affect inclusive and collaborative working relationships with WWS colleagues, including engaging SSRM Group Heads, Epidemiology Leads and other colleagues supplying sources of safety information. Actively engage global Regulatory, Clinical, Non clinical, Medical, and relevant individuals from in-country teams as needed.
  
  Qualifications (i.e., preferred education, experience, attributes)
  
• B.S., M.S. in health science
  
• Advanced degree preferred (PharmD, or Ph.D., or equivalents)
  
• Senior Manager RMPL - Minimum 5 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance but with a clear focus on drug safety risk management
  
• Director RMPL - Minimum 10 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance but with a clear focus on drug safety risk management
  
• Knowledge of global safety regulations and guidelines, or equivalent,
  
• Demonstrated experience in global drug safety risk management planning activities and generating RMPs
  
• Demonstrated strength in analytical skills and attention to detail.
  
• Demonstrated strength in oral/written communication, negotiation, and interpersonal skills.
  
• Demonstrated organizational/project management skills.
  
• Familiarity with management of performance metrics
  
• Significant knowledge of organization processes and matrix-based decision-making is required.
  
• Project management certification (PMP) and Six Sigma Certification preferred.
  
  Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy