Senior Medical Writer

As a Sr. Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Independently author most study-level documents at simple to complex levels, for example: 
  • Protocol, protocol outlines
  • Subject Information/Informed Consent
  • Clinical study reports (CSRs)
  • Lay summaries of clinical trial results
  • Investigator brochures (IBs).
• Provide support to more experienced writers with the preparation of submission and other complex clinical documents.
• Capable of interpreting and summarizing data.
• Drive discussions, ensure decisions are taken and incorporate project strategies in documents.
• Lead meetings and drive decisions concerning project/trial-specific medical writing issues.
• Responsible for all medical writing aspects of task finalization including stakeholder alignment, coordination, and adherence to timelines.
• Performs all other duties as needed or assigned.

En quoi consistera votre travail :

• Rédiger de manière indépendante la plupart des documents relatifs à l'étude, à des niveaux simples ou complexes, par exemple
    -Protocole, grandes lignes du protocole
    -Information du sujet/consentement éclairé
    -Rapports d'étude clinique (CSR)
    -Résumés vulgarisés des résultats des essais cliniques
    -Brochures de l'investigateur (IB).
• Aider les rédacteurs plus expérimentés à préparer les soumissions et autres documents cliniques complexes.
• Capable d'interpréter et de résumer des données.
• Diriger les discussions, veiller à ce que les décisions soient prises et intégrer les stratégies de projet dans les documents.
• Diriger des réunions et prendre des décisions concernant des questions de rédaction médicale spécifiques à un projet ou à un essai.
• Il est responsable de tous les aspects de la rédaction médicale de la finalisation des tâches, y compris l'alignement des parties prenantes, la coordination et le respect des délais.
• Effectuer toutes les autres tâches nécessaires ou assignées.

You are:

• Highly pro-active team player.
• Skilled in building and maintaining good working relationships with stakeholders and colleagues.
• Strong engagement with stakeholders to understand and align on the purpose/strategy, timing, and scope of MW tasks.
• Strong facilitation, communication and problem-solving skills to effectively manage interactions with all stakeholders and drive decision making.
• Represent MW in relevant project groups (e.g., trial squads, M&S team, Clinical Submission Team, Publication Planning Group).
• Contribute to knowledge sharing, skill building, and good collaboration with stakeholders and colleagues.
• Can work independently and demonstrate resourcefulness (refers to SOPs, guidance documents, and training before reaching out to others for answers to questions relating to medical writing procedures, etc.).
• Strong project management skills (organized, and effective time management).
• Take ownership and drive assigned tasks forward to progress documents to finalization.

Ce que vous devez posséder : 

• Esprit d'équipe très proactif.
• Aptitude à établir et à maintenir de bonnes relations de travail avec les parties prenantes et les collègues.
• Engagement fort avec les parties prenantes pour comprendre et s'aligner sur l'objectif/la stratégie, le calendrier et l'étendue des tâches liées au BEMM.
• Solides compétences en matière de facilitation, de communication et de résolution de problèmes pour gérer efficacement les interactions avec toutes les parties prenantes et favoriser la prise de décision.
• Représenter le BEMM dans les groupes de projet concernés (par exemple, les équipes d'essai, l'équipe M&S, l'équipe de soumission clinique, le groupe de planification de la publication).
• Contribuer au partage des connaissances, au développement des compétences et à une bonne collaboration avec les parties prenantes et les collègues.
• Peut travailler de manière indépendante et faire preuve d'ingéniosité (se réfère aux modes opératoires normalisés, aux documents d'orientation et à la formation avant de s'adresser à d'autres personnes pour obtenir des réponses à des questions relatives aux procédures de rédaction médicale, etc.)
• Solides compétences en matière de gestion de projets (organisation et gestion efficace du temps).
• Vous vous appropriez les tâches qui vous sont confiées et les faites avancer pour que les documents soient finalisés.

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

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

https://careers.iconplc.com/reasonable-accommodations

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.