Medical Writer II

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

What you will be doing:

• Leads a single team which guides medical writing activities within a designated therapeutic or functional area for key response documents and regulatory submissions.
• Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
• Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
• Coordinates the activities, contract employees and vendors (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues.
• Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and processes across development programs.
• Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
• As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
• Provides leadership on functional teams that address requirements or issues related to document preparation and production.

Responsabilités

• Diriger une équipe unique qui guide les activités de rédaction médicale dans un domaine thérapeutique ou fonctionnel désigné pour les documents de réponse clés et les soumissions réglementaires.
• Diriger la stratégie de rédaction en fournissant une expertise, y compris l’organisation, le contenu, les délais et les besoins en ressources.
• Fournir des données avancées plus complexes pour les conceptions d’études, les plans d’analyse, les sections concernant les PNMR et les applications marketing
• Coordonner les activités, les employés contractuels et les fournisseurs (sur place ou externes), assurer l’examen et l’édition de fond des contributions et assurer la résolution des problèmes.
• Dans le cadre de la fonction thérapeutique ou composée désignée, gérer les livrables et la préparation des documents à soumettre à la FDA ou à d’autres organismes de réglementation, en garantissant la cohérence du contenu dans les domaines thérapeutiques et le respect des exigences et des processus réglementaires dans l’ensemble des programmes de développement.
• Représenter la rédaction médicale au sein d’équipes et de groupes de travail interfonctionnels (liés aux projets, aux processus et aux normes).
• Au besoin, servir de rédacteur/rédactrice principal·e pour d’importants documents de réponse réglementaire et les principaux éléments des soumissions réglementaires.
• Assurer le leadership des équipes fonctionnelles qui traitent des exigences ou des problèmes liés à la préparation et à la production de documents.

You are:

• Bachelor’s degree in science, health profession, or journalism required.
• At least 5 plus years experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required.
• Experience as lead writer for key documents included in major US and/or international regulatory submissions required
• Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.

Knowledge and Skills: 

• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed product

Exigences :

• Diplôme de baccalauréat en sciences, dans une profession de la santé ou en journalisme requis.
• Au moins 5 ans d’expérience en rédaction dans le secteur pharmaceutique ou biotechnologique requis. Au moins 3 ans d’expérience de rédaction de documents électroniques et de soumissions requis.
• Expérience en tant que rédacteur·trice principal·e pour les documents importants inclus dans les principales soumissions réglementaires américaines et/ou internationales requises.
• Expérience dans la gestion d’activités de rédaction pour une importante soumission réglementaire américaine ou internationale (gestion de projets ou de personnes) souhaitée.

Connaissances et compétences : 

• Compréhension claire du développement clinique, y compris les phases, les processus et les techniques utilisées dans un environnement de développement clinique, de la conception du protocole à la soumission réglementaire et au soutien du produit commercialisé.

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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.