Principal, regulatory science and strategy - real world solutions

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PpIQVIA is focused on using data and science to help healthcare clients find better solutions for their patients. Individuals joining us are assured of a rewarding career in Life Sciences Consulting, with opportunities to address diverse and challenging client problems, contribute to cross-geography engagements, interact with senior client leaders, and gain exposure to a multicultural and collaborative work environment. /p h3About our team – Regulatory Science and Strategy (RSS) /h3 pThe Regulatory Science and Strategy (RSS) group sits within IQVIA's Real World Solutions business and supports life sciences clients in using real world evidence (RWE) more widely and effectively for regulatory purposes. RSS sells and delivers as a unified team, partnering with clients on regulatory strategy, study design, and submission planning across drugs, biologics, and devices. Our work spans externally controlled trials, post-marketing requirements (PMRs/PMCs), post-authorization safety studies (PASS), drug utilization studies (DUS), and emerging regulatory technology. /p pWe are strategic thinkers, deep subject matter experts, and creative at our core. We are collaborative, intellectually curious, and entrepreneurial. /p h3About the role: /h3 pAs a Principal (Director-level) within RSS, you will own delivery leadership, drive business development, and serve as a subject matter expert across two connected areas: selling and delivering standalone regulatory strategy engagements and cross-functional RWE studies for regulatory decision-making. Your work will focus primarily on several areas: /p pFirst, a Principal is expected to lead high-quality standalone regulatory strategy engagements, build trusted relationships with new and existing clients, and strengthen IQVIA's regulatory science and strategy capabilities. /p pSecond, the Principal acts as a subject matter expert on the use of RWE across the regulatory lifecycle, partnering cross-functionally with IQVIA Real World Solutions teams to shape, sell, and deliver RWE studies from pre-submission strategy through approval and post-market commitments. An in-depth understanding of EMA expectations is essential, with the ability to translate those expectations into study designs and submission strategies that clients can act on. /p pSpecifically, as a member of the RSS team, the Principal participates in regulatory strategy proposal development, advises on regulatory pathways, and supports cross-functional proposal strategy and delivery for externally controlled trials, PASS, DUS, RegTech advisory work, and broader RWE-for-regulatory engagements. /p pIn addition we expect you to make a key Team and operational contributions to RSS, including mentorship and capability building amongst your junior colleagues /p h3Responsibilities /h3 ul lipLead sell and delivery of standalone RSS regulatory strategy engagements,



owning workstreams end-to-end and supporting team members on complex programs. /p /li lipSupport cross-functional IQVIA Real World Solutions teams in selling and delivering RWE generation programs for regulatory audiences, including externally controlled trials, premarket uses of RWE, PASS, and PMR/PMC fulfilment. /p /li lipContribute to RSS regulatory intelligence activities, monitoring the external regulatory environment and surfacing emerging information relevant to IQVIA's offerings and clients. /p /li lipAct as a day-to-day owner of the regulatory science element of client engagements, with responsibility for client satisfaction and delivery quality. /p /li lipAdvise on strategy and delivery plans for RSS services, with a focus on EMA RWE activities and lifecycle management, supported by working knowledge of FDA, MHRA, Health Canada, and PMDA. /p /li lipMaintain working familiarity with the activities and outputs of EMA and their impact on global harmonization of RW efforts. /p /li lipIdentify follow-on work and new revenue opportunities with existing clients, and support business development efforts with new client organizations. /p /li lipCollaborate across IQVIA when client requirements span regulatory affairs, clinical development, and real world insights. /p /li lipProvide direction, advice, and intellectual leadership to delivery teams and clients. /p /li lipContribute high-level input to client reports and presentations, and deliver findings to clients directly. /p /li lipMentor and coach junior consultants, sharing subject matter expertise to build RSS capability. /p /li lipParticipate in annual performance review processes and in recruitment of new staff. /p /li /ul h3Skills and Experience /h3 pThe successful candidate will have a track record of success across most of the following competencies: /p ul lipbIndustry and regulatory expertise: /b Maintains a constant focus on regulators, industry, and client trends in life sciences. Applies this knowledge to active client engagements and to business development. /p /li lipbReal world data expertise: /b Ability to advise on the design of real world studies to meet regulatory requirements, including externally controlled trials, PASS, PMR fulfillment, etc. /p /li lipbRegulated medical product experience: /b Ability to speak with senior client stakeholders about EMA requirements, guidance, and expectations, with working knowledge of FDA, MHRA, Health Canada, and PMDA.



/p /li lipbClient relationship management and delivery: /b Day-to-day owner of client engagements, focused on client satisfaction and outstanding deliverables, with the ability to manage multiple workstreams in parallel. /p /li lipbBusiness development: /b Active contributor to proposal development and pre-sales meetings for standalone regulatory strategy opportunities and cross-functional RWE study opportunities with new and existing client organizations. /p /li lipbSolution selling: /b Ability to identify client pain points and shape custom solutions for life sciences clients. /p /li lipbCommunication and executive presence: /b Expresses ideas clearly and concisely, and tailors messaging to the audience. /p /li lipbCooperative teamwork: /b Builds supportive relationships within RSS and across IQVIA, based on trust and respect. /p /li lipbManagement of others: /b Sets clear direction and develops junior team members by delegating appropriately and creating stretch opportunities. /p /li lipCoping with decision-making, customer focus, flexibility, influencing, initiative, innovation, planning and organizing, strategic vision, and technological orientation. /p /li /ul h3Qualifications and Other Requirements /h3 ul lipA strong academic track record in a life science-related discipline or professional equivalent. A relevant graduate degree (PharmD, PhD, MD, MPH, or MS) is preferred. /p /li lipAt least 7 years of professional experience, with a meaningful portion focused on regulatory science, regulatory strategy, or product review. Prior experience at EMA or another health authority is highly valued. /p /li lipPrevious experience in life sciences consulting or professional services is preferred. /p /li lipEvidence of consistent career progression. /p /li lipA track record of project leadership and people development. /p /li lipWillingness and ability to travel to client locations. /p /li lipFluency in English (spoken and written). /p /li lipRight to live and work in the recruiting country. /p /li /ul pIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at /p pIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7nnryl