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  • Study Start Up Associate II  

    - Swansea
    At ICON, it’s our people that set us apart. Our diverse teams enable... Read More
    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

    Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

    That’s our vision. We’re driven by it. And we need talented people who share it.
    If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

    Study Start Up Associate II
    As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

    The Role
    • Proficiently negotiate CTAs, budgets and ancillary agreements.
    • Proficiently oversee all contractual documents and correspondence, including the facilitation of the indemnification process between Sponsor and Study Site.
    • Establish and maintain effective and proactive communication with Study Sites, Sponsors and internal personnel regarding the status of budgets, contracts and any other contract-related documents.
    • Ensure CTAs, budgets and ancillary agreements are negotiated within the Study specific agreed parameters and if not, appropriate approvals are obtained and documented.
    • As required, proficiently prepare, review and negotiate amendments to CTAs, budgets and ancillary agreements.
    • Conduct second level quality control review of completed CTAs, budgets and ancillary agreements prior to execution.
    Serve as the internal liaison on study site budgets with respect to country needs and requirements.
    • Forecast Budget and Clinical Trial Agreements execution timelines and ensures they are achieved; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified.

    What you need
    • A bachelor’s degree in Paralegal Studies, Juris Doctor (law) degree, or related experience is preferred.
    • SSU or Contracts experience at a CRO is desired.
    • Experience in a clinical research environment with specific experience in study contracts review and budget negotiation or in related field such as where contract or legal document review is a primary part of you role.

    Benefits of Working in ICON:
    Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

    We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
    We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
    But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

    ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
    If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. Read Less
  • Senior Medical Writer  

    - uk
    As a Senior Medical Writer you will be joining the world’s largest &... Read More
    As a Senior Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As a Senior Medical Writer you will be supporting a Top-5 pharma company. You have the chance to help our customer to deliver best-in-class regulatory and submission documents. While being stably employed with ICON, you will be fully embedded with our client.
    Responsibilities:  Independently produces clinical and regulatory documents in collaboration with Principal Medical Writers . These documents may include clinical study level documents such as Clinical Study Protocols or Clinical Study Reports. This includes Phase 1 in patients to Phase 3 across multiple therapeutic areas. Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies. Acts as the primary contact for the study team in relation to the preparation and timelines (incl. planning) of assigned documents. Facilitates the review of the documents and ensures that documents are submission-ready and finally approved. When preparing documents you will be directly in contact with QC personnel and publishing specialists who support you in document preparation.
    Minimum requirement of a bachelor’s degree; Master's degree preferred
    3-5 years Medical Writing experience or other relevant pharmaceutical experience combined with scientific and regulatory knowledge
    Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured messages.
    Proficient in independently writing several types of clinical/regulatory documents (mainly CSRs, Protocols) including leading creation, coordination of the authoring functions, facilitation of the review of the documents and ensuring that documents are submission-ready and finally approved. #LI-Remote Read Less
  • Biostatistician  

    - uk
    ICON plc is a world-leading healthcare intelligence and clinical rese... Read More
    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
    What you will be doing: Responsible for planning, managing and execution of statistical deliverables in clinical trial and non-trial activities in the project Responsible for providing statistical input to authority required documents or meetings Responsible for ensuring that clinical trial and non-trial tasks are aligned with the project specifications Deliver results through and ensure understanding among colleagues relevant for problem-solving Lead project teams to achieve milestones and objectives Prioritize, plan, manage and execute Clinical Trials and submissions within project area Mentor and develop successors within project area Fully responsible for statistical methodology and deliverables within the project Main contact to stakeholders regarding statistics within the project
    You are: MSc. in statistics or equivalent +3 years of experience as a statistician within the pharmaceutical area or equivalent knowledge through relevant experience Experience with a broad range of statistical tasks In-depth knowledge of biostatistical methods Extensive experience with practical applications of biostatistical methodology In-depth knowledge of drug development Broad experience with statistical software and IT and in-depth experience with at least one statistical software package Good knowledge of GCP and statistical guidelines within drug development Regular experience with communication of statistical issues and presentations Basic understanding of the pharmaceutical industry and key elements of the value chain, with a focus on immediate stakeholders and how to deliver on own goals
    What ICON can offer you:

    Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

    In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

    Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

    Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

    ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

    Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Read Less
  • Statistical Programmer  

    - uk
    ICON plc is a world-leading healthcare intelligence and clinical rese... Read More
    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
    What you will be doing: Responsible for planning, managing and execution of statistical programming deliverables in clinical trial and non-trial activities in the project Responsible for providing input to authority required documents for the trial and non-trial activities Responsible for ensuring that clinical trial and non-trial tasks are aligned with the project specifications Responsible for continuous development of own skills and to contribute to the development of Biostatistics
    You are: +3 years of statistical programming, and preferably 1 year within the pharmaceutical industry or equivalent knowledge through relevant experience Extensive experience with programming in e.g. SAS or R Experience with reporting clinical trials, including statistical data handling, analysis and reporting Experience with review and documentation of programs Good knowledge of drug development What ICON can offer you:

    Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

    In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

    Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

    Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

    ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

    Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Read Less
  • Principal Medical Writer  

    - uk
    As a Principal Medical Writer you will be joining the world’s largest... Read More
    As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As principal medical writer, you will be supporting a Top-5 biotech company. You have the chance to help our customer to deliver best-in-class regulatory and submission documents. While being stably employed with ICON, you will be fully embedded with our client. Your excellence in medical writing will help them reduce time to market of their deep antibody pipeline. The position is home-office based. Your contribution will be in the challenging field of autoimmune diseases. While working for our client, you will be able to profit from ICON through continued learning opportunities and building a longer-term career.
    What you will be doing:

    Medical Writing Excellence You will deliver all types of clinical, regulatory, and submission documents. You will draft and manage documents that are superbly organized, accurate, consistent, unambiguous and written for the target audience. Key documents to develop will be clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, eCTD modules and other clinical and regulatory documents. You will take up a lead role in advising and guiding clinical teams on content and processes. You will ensure that all applicable company SOPs and regulations are upheld. Lead in a multi-shareholder environment to ensure seamless delivery of best-in-industry regulatory documents. Closely interact with clinical program leadership and clinical teams to set up and safeguard challenging project deadlines. Functional Leadership You will be a pivotal member of clinical teams in pro-actively guiding them on best-in-class medical writing processes. You will drive consistency of documentation using document templates and company style guide across programs Ensure dissemination of industry and health-authority regulatory guidelines. Represent medical writing function at internal meetings (e.g. project and program management status updates). You will proactively provide recommendations for potential process improvements to foster best-in-industry delivery of regulatory documents of the highest quality. May represent Medical Writing department in industry standards working groups. Represent the medical writing function during an audit of clinical trial documents to
    guarantee timely response to findings
    You are:

    Minimum of 6 years of pharmaceutical/biotechnology-related medical writing required Master degree in a scientific, medical or clinical discipline or related field required, PhD preferred Can interpret and implement all FDA and ICH guidelines for clinical reporting. eCTD development and submission experience preferred. Pivotal understanding of key phases, processes, and techniques of drug development from protocol development through submission. Excellent communicator and driver of cross-functional collaborations. Innovative mind-set and proactive contributor of process improvement ideas. Ability to proofread documents for compliance with internal and external guidance
    Can drive consistency of documents across indications. Experience in electronic publishing preferred. Benefits You will be provided with a comprehensive and very competitive total reward package that comprises an excellent level of base pay completed with a wide range of variable pay and recognition programs. We offer you best-in-class employee benefits, supportive policies and wellbeing initiatives tailored to support you and your family at all stages of your career with ICON. You will profit from being a key medical writer at a Top-5 biotech company, all the while being a full employee of ICON. ICON is an equal opportunity and inclusive employer. Why ICON?

    Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

    Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

    ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

    Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Read Less

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