Regulatory Affairs Associate

An Associate must have a knowledge of the organization’s basic consulting models and methodologies as well as basic knowledge of what services PC provides. An Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. An Associate, under the general direction of a Project Lead and/or Technical SME, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. The guidance of more senior staff may be needed to accomplish more complex tasks. An Associate may act in a client facing role with clear guidance and support from line management.Key AccountabilitiesProject ExecutionWorks effectively within a team environmentWorks within broad project guidelines as directed by the Project Lead or Technical SMEWith the guidance of the project Technical SME, demonstrates the ability to prioritize work to achieve specified project outcomesCapitalizes on opportunities to improve one’s own performance and seeks feedback from the Project Lead and colleaguesApplies information provided by the Project Lead or senior colleagues to complete assigned project activitiesProduces quality work that meets the expectations of project lead and the clientMay serve as a Project Lead for small scale projects or a Work Stream Lead on larger projectsWhen serving as a Project Lead with clear guidance and support from Line ManagerResponsible for project planning and set-up and routinelyinteracts with the assigned Project Specialist (PS) or ProjectManager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.)Functions as the main client contact and ensures accurate project reporting is in placeEnsures that the project team delivers to meet the client expectations for quality and timelinessEnsures that appropriate risk identification and issue-escalation procedures are in placeEnsures project specific training compliance of the project teamEnsures and/or manages project financials including provision of accurate revenue forecastsEnsures that the project team understand and work to the scope of the contractIdentifies new opportunities through Change In Scope or add-on business from existing workEnsures timely project close-out activities are completedConsulting Activities and Relationship ManagementFollows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or Technical SMEDelivers a limited range of consulting services within personal area of expertise under the guidance of the Project Lead and/or Technical SMECompletes assigned activities within project scope and objectives under the direction of the Project Lead and/or Technical SMEIdentifies project and internal issues to senior colleagues and Project Lead and/or Technical SMEInteracts professionally at all working levels within a client organization and within ParexelIdentifies project and/or client needs to the Project Lead and/orTechnical SMEInteractions result in clients expressing satisfaction with service providedBusiness DevelopmentBegin networking within the industry (i.e. maintain contacts and relationships with clients once engagements are complete)Communicates potential new business lead to PC management and account managersParexel-related ActivitiesMeets established metrics as specified in scorecard on an annual basisCompletes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projectsDefines self-development activities with the support of management in order to keep current within the industrySkillsProject management knowledgeClient-focused approach to workResults orientationTeamwork and collaboration skillsConsulting skillsExcellent interpersonal and intercultural communication skills, both written and verbalCritical thinking and problem-solving skillsProficiency in local language and extensive working knowledge of the English language Knowledge And Experience1-2 years of experience in preparing regulatory dossiers for submissions to the regulatory authority in Argentina -Clinical Trials Applications and maintenance Initial years of experience in an industry-related environment EducationMinimum of a Bachelor’s Degree in a Scientific Discipline