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Parexel
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  • When our values align, there's no limit to what we can achieve. We are... Read More
    When our values align, there's no limit to what we can achieve.
     
    We are currently looking to recruit an experienced Principal RWD Strategy Lead to join us in multiple EMEA locations About The Role:The Principal RWD Strategy Lead is a functional hands on role, with minimally 5-7 years experience, leading RWD strategy for studies and supporting regional RWD capabilities. The Principal Data Strategist is an expert role, leading the development of the real-world data (RWD) strategy used in a given solution leveraging RWD, ensuring it is fit-for-purpose and is used in a manner compliant with the data use agreement and applicable laws. This individual can cover multiple geographic regions (but with an expertise in European RWD landscape), will be client facing and is able to support a variety of research needs. Subject Matter expertise is provided by the Principal to users of the data to ensure that use is optimized. The role works closely with data sources, technology / solutions / contract teams, epidemiologists, statisticians and medical, and can act as a data source relationship owner aligned to Global Real-World Data Strategy. It is a leading role with strong visibility opportunities and career progression options.What You'll Do At Parexel:The Principal Data Strategist will lead the development and deployment of a RWD strategy for client opportunities and proposals as well as awarded work. This individual is comfortable working in a fast-paced environment with cross-functional and client teams to execute the RWD strategyWhere defined, the Principal works in alignment with the Global & Regional RWD Strategy Heads, to serve as relationship manager and primary point of contact for data providers; participate in establishment of governance structure for data relationship building (e.g. Including regular meeting on status, performance, capability, emerging requirements); identifies ways in which the partnership can be strengthened (e.g., improve direct access, feasibility turnaround); ensures data partners' needs/expectations are being met; and works with Procurement/LRM to establish/manage MSAsThe Principal handles complex issues related to data applications and/or analysis requirements and how to remedy them. This individual serves as a SME to the business on the use of the data in clinical research and, where appropriate, identifies, assesses, and recommends appropriate options to expand access to RWDThe Principal will develop working knowledge of RW data sets assigned to strategy leader, keep specifications up-to-date in the data catalog (e.g., new functionality); contribute to the evaluation of data requirements to optimize services; support the growth of the Real World Research market share; assist in the development of descriptive content that can be used in capability presentations, proposals, protocols/SAPs, study reports, etc. for the content library; support wider the wider RWD organization as directed, including working relationships with business units, clients and RWD and Real World Reserach functional teams, vendors, providers; at minimum, Epidemiology, Market Access, Patient Engagement, TAs, Strategic Feasibility, Global Data Operations, Corporate IT, Legal and Risk Management, Procurement, Data Privacy, Project team personnelLastly, the Principal must ensure compliance with operating standards, policies, regulations, SOPs, privacy and data security standards, facilitate project-specific contracting need; as directed / needed, represent Parexel, with guidance, in professional societies and at key events and meetings. This individual is expected to have a strong understanding of clinical research, real world data, and healthcare; experience in budgets, cost evaluation, project management; strong analytical and problem-solving skills and ability to manage multiple projects with a decentralized teamThe Principal RWD Strategy Lead’s key responsibilities will include:Supporting complex RWD RFIs, RFPs and projects independently, provision of RWD deliverables in accordance with contractual requirements, governing SOPs / regulations, and data / quality standardsCollaborating with multidisciplinary teams, in partnership with RWR Delivery Leads to leverage RWD for a variety of study designs across all geographiesDetermining the best methods for partnering with health systems, data vendors, national/regional patient registries, disease-specific registries, and other novel sources of RWD for client accountsEngaging in key scientific and medical strategy discussions with epidemiologists, data engineers, statisticians, medics, and clients to inform advanced RWD strategiesLeading key project level engagements with data source providers demonstrating strong domain knowledgeMentoring junior team membersActing as RWD domain expert in client engagementsSupporting enterprise RWD strategiesRequired skills, experience, and education:5+ years of industry experience (CRO/Pharma/Data Vendor) with the ability to demonstrate the following: Strong data science/data analytics experienceStrong understanding of the clinical research process and business, medicines and medical device development, healthcare market, and related sectorsFluent EnglishDemonstrated ability to apply scientific or real-world data solutions to address clinical or commercial questions and needs Experienced in budgets and cost evaluation of RWD based solutions Strong understanding of project management principles Advanced degree in biomedical informatics, public health, data science, life sciences, or related field required Excellent oral and written communication skills Strong customer focusAbility to manage multiple projects Ability to work with a decentralized team, with a proactive desire to learn from experienced team members Strong analytical and problem-solving skills Ability to partner with stakeholders in the business to learn and translate their needs to real-world scientific data requirements  Read Less
  • Senior Manager, Biostatistician Consultant  

    - London
    When our values align, there's no limit to what we can achieve. The Pr... Read More
    When our values align, there's no limit to what we can achieve.
     
    The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert.Key Accountabilities:Operational ExecutionProvide broad statistical support, including trial design, protocol and CRF development on specific studies.Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols.Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans.Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review.Business DevelopmentSupport of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings.General ActivitiesUnderstand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis.Understand, apply and provide training in extremely advanced and sometimes novel statistical methods.Contribute to the development and delivery of internal and external statistical training seminars and courses.Review position papers based on current good statistical practice.Interact with clients and regulatory authorities.Review publications and clinical study reportsTravel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results)Additional responsibilities as defined by supervisor/manager.Skills: Good analytical skills.Good project management skills.Professional attitude.Attention to detail.Thorough understanding of statistical issues in clinical trials.Ability to clearly describe advanced statistical techniques and interpret results.Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines).Prior experience with SAS programming required.Ability to work independently.Good mentoring/leadership skills.Good business awareness/ business development.Knowledge and Experience:The knowledge of pharmacokinetic data is an advantage.Competent in written and oral English Education: PhD in Statistics or related discipline, MS in Statistics or related discipline. Read Less
  • When our values align, there's no limit to what we can achieve. Parexe... Read More
    When our values align, there's no limit to what we can achieve.
     
    Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability.We are currently recruiting for Clinical Research Associate II and Senior Clinical Research Associate to join our Multi-Sponsor Clinical Trials Team in the UK. This role if fully decentralised in the UK.Your time hereAt Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they’re set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You’ll also manage site quality and delivery from site identification through to close-out.As a CRA, Parexel will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work may be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas and an opportunity to advance your career in clinical research. If impact, flexibility, and career development appeal to you, Parexel could be your next home.What you’ll doLeverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol.Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability.Execute. Monitor the completeness and quality of Regulatory Documentation and perform site document verification.More about youOn your first day we’ll expect you to have:Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.Ability to perform all clinical monitoring activities independently.Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.Strong interpersonal, written, and verbal communication skills within a matrixed team.Experience working in a self-driven capacity, with a sense of urgency and limited oversight.A client-focused approach to work and flexible attitude with respect to assignments/new learning.The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).An honest and ethical work approach to promote the development of life changing treatments for patients.Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.If you are ready to join Parexel’s Journey, please apply! Read Less
  • Senior / Principal Medical Writer - FSP  

    - London
    When our values align, there's no limit to what we can achieve. Parexe... Read More
    When our values align, there's no limit to what we can achieve.
     
    Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. We believe in our values,Parexel are recruiting for either a within our groupThe FSP team is an that fulfills key clinical development roles across a variety of functional disciplines including medical writing.As the you will support clinical study reports (CSRs), including narratives, plus study protocols and protocol amendments, common technical document (CTD) sections (e.g., Modules 2.5 and 2.7) and other documents for submission to regulatory authorities for one of our key clients sponsored studies.The role can be based in eitheror and can be You will be working in an innovative and collaborative environment with international peers, colleagues and a supportive manager.Key Accountabilities:Author Clinical DocumentsGather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training.Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.Manage ongoing and/or revised project documentation and correspondence.Quality ControlEnsure that all work is complete and of high quality prior to team distribution or shipment to client.Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission.Project ManagementOperate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents.Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project.Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences.Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence.Client Liaison/ServiceBe aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management.Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon.Training / ComplianceKeep abreast of new advances in medical writing and regulatory issues.Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management.GeneralAttend departmental and company meetings as necessary.Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platformEducation:Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.Skills:Excellent interpersonal, negotiation, verbal, and written communication skills.A flexible attitude with respect to work assignments and new learning.Motivation to work consistently in a fast-paced, rapidly changing environment.Ability to manage multiple / varied tasks with enthusiasm and prioritize workload with attention to detail.Competent working in a matrix environment and values the importance of teamwork.Possesses team leadership skills and cross-cultural sensitivity.Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate.Presents solutions and follows through to ensure problems have been satisfactorily resolved.Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.Understands and satisfies client needs.Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company.Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy.Knowledge and Experience:Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.Previous advanced level medical writing experience operating at either Senior or Principal Medical Writer level, being able to demonstrate broad experience in preparation of all types of clinical regulatory documentation.Experience with clinical study reports (CSRs), Safety narratives, study protocols and protocol amendments, common technical document (CTD) sections particularly Modules 2.5 and 2.7 is essential.Experience in management of complex medical writing projects.Knowledge of resource management and productivity metric management.Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).Fluent English communication skills in both written and verbal format.In return we will be able to offer you a structured career pathway and encouragement to develop within the role including awareness and understanding of the industry. You will be well supported and in return for your hard work you will be rewarded with a competitive base salary and a benefits package including holiday, private healthcare as well as other benefits that you would expect with a top company in the CRO Industry.#LI-LG2 Read Less
  • Regulatory Affairs Generalist (home or office based)  

    - Harrow
    When our values align, there's no limit to what we can achieve. We are... Read More
    When our values align, there's no limit to what we can achieve.
     
    We are seeking a dedicated Regulatory Affairs Professional to join our growing team. This role offers an opportunity to work with global and local regulatory teams, supporting product lifecycle management and ensuring compliance with health authority requirements. The role can be home or office based in various European locations. Role Responsibilities: Support global and/or local regulatory teams with comprehensive understanding of regional and global regulatory requirementsManage post-authorization lifecycle maintenance procedures (variations, renewals, PSURs) for multiple licensesCoordinate health authority interactions and responses to questionsPrepare and organize local-specific documentation (Module 1) to meet national submission requirementsMaintain up-to-date local national systems according to local legislationManage impact assessments for technical changes affecting marketing authorizationsStay current on regulatory requirements and guidelines to ensure complianceSupport health authority inspections as neededProvide technical and business consulting services within area of expertiseComplete activities within project scope, timeline, and objectivesSkills and Experience required for the role: University Degree in a Scientific or Technical DisciplineA few years of experience in an industry-related environmentExperience in regulatory authority-facing rolesRegulatory Operations (Submission management) experienceExperience using Veeva Vault RIMS - strong plusOutstanding interpersonal and intercultural communication skills (written and verbal)Critical thinking and problem-solving abilitiesFluent in English, written and spoken Read Less
  • Clinical Catering Assistant [BANK]  

    - Harrow
    When our values align, there's no limit to what we can achieve. Come a... Read More
    When our values align, there's no limit to what we can achieve.
     
    Come and join our team at Parexel’s Early Phase Clinical Unit in Harrow as a Clinical Catering Assistant. This is a BANK role will be offering flexible shifts, including weekends.The main purpose of this role is to distribute food and beverages to clinical trial participants, and to maintain the catering area.

    Job Responsibilities:

    Providing meals to participantsCoordination and ordering food from caterer for volunteers in cooperation with the study teamDistribute food and beverages to trial participants according to study protocol and internal requirementsSupervise volunteers during mealtimes, assisting them with catering requirements, as requiredEnsuring menus have macro-nutrients checked by the DieticianFollowing study protocolEnsure that the meals are correct (ingredients and macro-nutrients) and distributed as per protocol timeDocument meal and beverage start and stop times when required by a studyDocument beverages distribution times and provided volumes as per source data agreementWeigh food before and after when demanded by the study protocolEstimate percentage consumption when required by protocolMaintaining catering areaStore food and beverages according to individual storage requirementsPerform quality controls on expiry dates of stored food and drinksClean and maintain kitchen and equipmentMaintain stock.Oversee staff kitchen areas and maintain stock levels as requiredUnit supportHospitality set-up and oversee food ordersOther tasks in the opinion of the manager and need of the EPCUSkills & Experience:Experience in restaurant or canteen work or equivalentBasic English knowledgeComputer skills (Windows Office)Ability to work under pressure and multitask in times with a higher workloadAbility to work in shifts (early, late)Ability to work on weekends and holidaysGood communication skillsTo handle and operate the dishwasher, the heated catering trolley ovens, the kitchen ovens and other machinery as and when required with health and safety in mindEducation:A secondary school qualification. Read Less
  • General Manager, FSP Biometrics Operations  

    - London
    When our values align, there's no limit to what we can achieve. The FS... Read More
    When our values align, there's no limit to what we can achieve.
     
    The FSP (Functional Service Provider) General Manager (GM) provides strong leadership and oversees strategic, operational, and financial management of FSP programs for a key customer account. The GM ensures high-quality, cost-effective services, drives business growth, maintains customer relationships, and ensures regulatory compliance. Through leadership, collaboration, and resource optimization, the GM promotes operational excellence, customer satisfaction, and overall success. The GM works closely with the Commercial Account Lead and FSP Program/Functional Leads to drive growth aligned with account strategy and Parexel's priorities.Key AccountabilitiesBusiness OperationsAct as the primary point of contact for customers at the account level for FSP programs.Ensure the effective and efficient delivery of FSP services. This includes establishing and maintaining quality management systems, functions, performance metrics, implementing process improvements, and ensuring adherence to regulatory requirements and industry standards.Accountable for the financial aspects of the FSP account, including budget planning, resource allocation, cost management, and financial reporting. This involves ensuring profitability (revenue, hiring, and margin targets), monitoring customer contracts, and identifying opportunities for cost savings or revenue generation.Manage the assigned staff to the FSP account, including identifying staffing needs, recruiting, and selecting team members, assigning resources to projects, reviewing invoicing, and optimizing resource utilization. This is done in partnership with the program/functional leads.Collaborate effectively with other functional areas across Parexel to ensure seamless integration and coordination of services for the customer.Advise and provide strategic direction to functional/program leads on overall margin improvement opportunities at account level, including labor cost of the billable FTE and overhead costs.Account Management and Growth StrategyDevelop and implement the strategic direction for the FSP account aligned with the overall goals and objectives of the customer account and Parexel. This includes setting operational priorities, identifying opportunities for growth and expansion of roles and services into other functional areas, and establishing performance targets.Define customer specific needs and improvement areas across the FSP account in alignment with their strategic priorities and our capabilities. Ensure the overall satisfaction of the customer.Build, nurture, and maintain key FSP account leadership relationships and communication with customer and internally.Engage FSP customer and internal key stakeholders (inclusive of executive C-Level) in regular governance meetings to review account status and performance.Engage handover from pre-award to post-award as the primary account point of contact for the FSP customer.Maintain extensive knowledge of customer pipelines/ products/ growth strategies.Delivery Oversight & Performance Monitoring Account level oversight for all aspects of FSP operational delivery, including, timely and quality delivery across customer portfolio.Drive operational excellence within the FSP account through best practices, SOPs, and performance metrics. Foster a culture of continuous improvement, define, monitor and report on KPIs, address operational challenges, and support year-over-year improvement in efficiency, quality, risk mitigation and delivery outcomes in collaboration with program/functional leads.Develop & maintain executive summary of operational performance for portfolio of programs across the FSP account.Business DevelopmentAssume accountability for identifying and pursuing new FSP business opportunities within existing accounts. Collaborate with the Commercial Account Lead and FSP Solution Consultants to engage customers, negotiate agreements, and drive overall FSP growth in support of account targets.Define the FSP Strategic Account growth strategy, customer engagement level, and objectives aligned with corporate goals and the broader account strategy. Take the lead on repeat business opportunities, including RFP/BDM, and provide subject matter expertise for proposals and bid defense meetings.Line ManagementManage employee performance through continuous feedback, goal setting, and performance reviews. Strengthen project delivery and employee satisfaction.Effectively hire and onboard new employees, selecting high-caliber candidates aligned with customer and Parexel's needs. Provide a consistent and positive new hire experience.Sponsor a fit-for-purpose training curriculum and ensure compliance with systems and processes.Provide coaching and mentoring that fosters adaptability, collaboration, and next-line leadership development.Enhance engagement and retention through career development, team engagement, and proactive guidance.Lead team through successful adoption and implementation of organizational changes.Process ImprovementChampion process improvement in enterprise-wide strategic initiatives in partnership with other functions and the Operational Excellence and Delivery Office.Skills:Deep understanding of FSP environment at the market and customer level (pipelines/finances/ etc.).Strong understanding of financial management, including budgeting, forecasting, and cost control.Strong leadership skills, including the ability to inspire, motivate, and drive high performance., collaboratively build relationships across disciplines, including the commercial/operations partnership with the customer, demonstrating high emotional intelligence.Solid understanding of project and portfolio level financial reports (Rev/NBA/Margin).Ability to define KPIs, analyze performance, track metrics, and generate accurate reports.Excellent problem-solving skills in a complex environment (internal and external).Proficiency in portfolio/account strategy planning.Ability to set clear performance expectations, establish metrics and goals, conduct regular performance evaluations, and provide ongoing feedback.Leverage analytics for strategy, negotiations, and effective solution implementation by analyzing information, considering alternatives, and implementing effective strategies.Knowledge and Experience:Proven substantial expert project management experience, preferably in healthcare, clinical research, or contract research organization.Deep experience in FSP leadership and management roles, clinical research operations, customer relationship management.Understanding of business development and sales.An operational understanding of quality and compliance managementExperience in leading business improvement change efforts. Strong command of written and spoken English language, local language proficiency as required.Education:Bachelor’s degree or equivalent level of education (science or medical related field preferred) or proven substantial management experience. Advanced degree (science, medical, business) desirable. Read Less
  • When our values align, there's no limit to what we can achieve. We are... Read More
    When our values align, there's no limit to what we can achieve.
     
    We are seeking a dedicated Regulatory Affairs Labelling professional to join our growing team! This role offers an opportunity to work with global labelling teams, ensuring regulatory compliance and supporting product labelling management across multiple regions.The role can be home or office based in various European locations. Role Responsibilities:Support Global Labelling, Regulatory (Clinical/Safety), or Medical Writing teams for labelling updatesManage Company Core Datasheet (CCDS) implementation into labelling and artworksIdentify triggers for CCDS updates and coordinate impact assessments for technical changesApply knowledge of Safety Signal Management and its impact on labellingNavigate CCDS governance processes in pharmaceutical environmentsUnderstand Periodic Safety Update Reports (PSUR) and their potential impact on labellingManage the relationship between labelling and artwork processesImplement regulatory processes required to update product labelling (various variation categories)Prepare Addendum to Clinical Overview (Module 2.5) to support labelling variationsApply regulatory requirements for labelling updates across different regions (EU, EAEU, US, APAC)Manage SmPC, PIL and QRD requirements, EU linguistic reviews, and translation activitiesCoordinate readability and PIL testing processesReview and approve consumer-facing materials in accordance with approved labellingParticipate in promotion review committees and provide regulatory guidance for local marketsProvide technical and business consulting services within area of expertiseComplete activities within project scope, timeline, and objectivesSkills and Experience required for the role: University Degree in a Scientific or Technical DisciplineInitial years of labelling/regulatory experience with global responsibilitiesRegulatory Operations (Submission management) experienceOutstanding interpersonal and intercultural communication skills (written and verbal)Critical thinking and problem-solving abilitiesFluent in English, written and spoken Read Less
  • Senior Regulatory Affairs Strategist (home or office based)  

    - London
    When our values align, there's no limit to what we can achieve. Parexe... Read More
    When our values align, there's no limit to what we can achieve.
     
    Parexel is seeking an experienced Regulatory Affairs Professional to join our dynamic team as a Senior Regulatory Affairs Consultant. This strategic position requires a proactive and agile regulatory professional able to build strategy, drive execution, and address challenges involved in gaining market approvals across international regions. You will provide expert guidance to our clients and delivery teams while managing multiple projects in a fast-paced, results-oriented environment.The role can be home or office based in various European locations.Key Responsibilities:Strategic LeadershipDevelop comprehensive international regulatory submission strategies for a wide variety of products and projects including CTAs, MAAs and Lifecycle management.Provide strategic guidance to clients and delivery teams on requirements and submissions across international regionsSupport or act as Project Lead, working with local market Regulatory Affairs experts to optimize strategies for specific submissionsSubmission ManagementGuide delivery teams in the creation and maintenance of international dossiersDrive and manage multiple regulatory submissions simultaneouslyEnsure effective regulatory representation in partnership with appropriate technical experts at health authority meetingsDocument discussions and agreements with regulatory authorities clearly and comprehensivelyRegulatory IntelligenceMonitor and stay abreast of key changes in the regulatory environment of international marketsCreate and perform regulatory intelligence surveysProvide objective assessment of intelligence dataCommunicate regulatory requirements and propose submission strategies to clientsTeam LeadershipCoach, mentor and lead regulatory teams to ensure objectives are successfully delivered on time and with qualityIdentify and mitigate risks with respect to international submissionsGuide cross-functional team discussions and drive regulatory solutionsSkills and Experience required for the role: University degree in a relevant scientific discipline (e.g., Biomedical Sciences, Chemistry, Pharmaceutical Sciences)10+ years of experience in the pharmaceutical/biotech industry, with substantial experience in Regulatory AffairsBroad background in pharmaceutical business and experience in several areas within regulatory affairs (e.g., Global, European, International, Marketing Company or health authority experience)Experience with biologics/vaccines/infectious diseases/oncology and rare diseases strongly preferredLeadership in managing regulatory agency negotiations and organizing Scientific Advice Meetings with health authoritiesStrong knowledge of CTD format and eCTD submission builds, including preparation of Modules 1-5 documentsExperience with Clinical Trial Applications and regulations relating to clinical trialsStrong influencing, negotiation, and relationship management skillsAdvanced problem-solving skills and drive to generate compliant regulatory solutionsFluent English, written and spoken Read Less
  • When our values align, there's no limit to what we can achieve. Summar... Read More
    When our values align, there's no limit to what we can achieve.
     
    Summary of This Role:-This Senior Consultant;* leads and oversees complex evidence evaluation and network meta-analysis (NMA) projects, ensuring the use of robust methodologies and high-quality outputs.* provides statistical capabilities and methodological leadership throughout all project stages, from planning to completion.* leverages his/her expertise in evidence synthesis, systematic review methodologies, and advanced statistical techniques to design, develop, and deliver client solutions.* applies proficiency in statistical theory, data analysis and interpretation, regression analysis, and various statistical software tools (such as WinBugs, R, Stata, Python, and SAS) to drive project success.This role requires a Master's or Doctoral Degree in Health Economics, Health Policy, Statistics, Biostatistics, Mathematics, or other related quantitative fields.Knowledge and Experience:Training and extensive experience in health economics, including the conceptualization and development of systematic literature reviews and network meta-analyses (8+ years, ideally in a consultancy environment)Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as the development of predictive equations, survival analysis (including parametric methods), longitudinal data analysis, meta-analysis, mixed treatment comparison, and other hierarchical analysis techniquesFamiliarity with machine learning techniques and Bayesian statistics is a plusStrong communication (spoken and written) and problem-solving skills, and an ability to learn quicklyAbility to communicate effectively, in non-technical terms, with project team members and clientsExperience in managing projects and leading/coaching a project teamKeen interest in medical research, provision of healthcare, and the pharmaceutical industrySkills:Strong computing skills (MS Office), including MS ExcelHigh analytical abilityExcellent scientific, business writing, and presentation skills with close attention to detailAbility to work under pressure to meet multiple and sometimes competing deadlinesExceptional communication skills, both oral and in writing, especially in the relaying of technical information and what is essential and strategic to the clientSelf-motivation, enthusiasm, ambition, and flexibilityCompetent in written and spoken EnglishSoftware: SAS (Base, Stat, Graph, Macro), R, SPSS, STATA, and WinBUGS; Python is a plusEducationMaster’s degree or equivalent in either life science or a quantitative discipline, such as health economics, economics, mathematics, or statistics Read Less

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Astrid-Lindgren-Weg 12 38229 Salzgitter Germany