Regulatory Affairs Consultant - Core Team at Parexel | Torre

Regulatory Affairs Consultant - Core Team

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Freelance
Recurrent
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Remote (for Australia residents)
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Emma of Torre.ai
17 days ago

Responsibilities


Key Accountabilities:Project ExecutionTypically works within a team environment but may work independently delivering services within their technical area of expertiseWorks within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflictsDemonstrates ability to prioritize work and define steps needed to achieve specified project outcomesCapitalizes on opportunities to improve one’s own performance and may provide suggestions for improving project efficiencies and results to the project technical leadSeeks out information from previous projects, other client work or from colleagues to complete assigned project activitiesProduces quality work that meets the expectations of project Team Lead and the clientMay serve as a Project Lead for small scale projects or a Work StreamLead on larger projects When serving as a Project LeadResponsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (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 methodologiesProvides technical and/or business consulting services within personal area of expertiseCompletes assigned activities within project scope and objectives with an understanding of issues which may impact project profitabilityCollaborates with colleagues and client to identify and resolve technical and process issuesLeverages senior colleagues to discuss and propose resolutions to possible problems or conflicts. Seeks guidance periodically on appropriate methods of executing project activitiesInteracts professionally at multiple levels within a client organization and within ParexelProactively assesses client needs and develops processes and solutions to address issuesDelivers assigned work and provides services and solutions which results in clients expressing satisfaction with service providedInteractions result in clients expressing satisfaction with service providedMay prepare and/ or deliver presentation with the support of senior colleaguesMay deliver trainingMentor of junior staffIdentifies and alerts PC management to opportunities for follow-on business or necessary changes in project scopeBusiness DevelopmentContinue to build a network of industry colleagues through relationships formed during project engagements or through other industry experienceCommunicates potential new business leads to PC management and account managersMay participate in project scoping calls and/or proposal preparation with the support of senior colleaguesParexel-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/projects or as a mentor as requested by managementDefines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)Skills:Project 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 languageKnowledge and Experience:Several years of experience in an industry-related environmentEducation:Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree PreferredParexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere.Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™