Job Description

Sr. Medical Writer- Remote Canada
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
We are currently seeking a Senior Medical Writer to join our diverse and dynamic team. As a Senior Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of inNvative treatments and therapies.
What you will be doing

• Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy, clarity, and compliance with regulatory guidelines and industry standards.

• Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, summarize scientific findings, and communicate key insights in written form.

• Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives.

• Contributing to the development of publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences, disseminating study results and scientific insights to the broader scientific community.

• Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles, and fostering a culture of excellence, collaboration, and continuous learning within the medical writing team.

Your profile

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechNlogy, or contract research organization (CRO) industry.

• Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills, and the ability to communicate scientific concepts to diverse audiences.

• Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process.

• Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritizing tasks based on project timelines and deliverables.

• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes.

Redacteur Medical Principal (Senior Medical Writer)
Nous recherchons actuellement un Redacteur Medical Principal pour rejoindre notre equipe diversifiee et dynamique. En tant que Redacteur Medical Principal chez ICON, vous jouerez un role cle dans la direction du developpement et de la mise en oeuvre des strategies de redaction medicale pour les projets de recherche clinique, contribuant ainsi a l'avancement de traitements et therapies innovants.
Vos responsabilites
Diriger la preparation, la relecture et la revision des documents d'etudes cliniques, notamment les protocoles d'etude clinique, les rapports d'etude clinique (CSRs), les brochures investigateur (IBs) et les dossiers de soumission reglementaire, en veillant a leur exactitude, leur clarte et leur conformite aux directives reglementaires et aux normes de l'industrie.
Collaborer etroitement avec les equipes transverses -- recherche clinique, biostatistiques, affaires reglementaires et affaires medicales -- afin d'interpreter et d'analyser les donnees d'essais cliniques, de resumer les resultats scientifiques et de communiquer les principales conclusions sous forme ecrite.
Participer a la planification et a la mise en oeuvre des programmes de developpement clinique, en apportant une contribution strategique et une expertise scientifique pour soutenir la conception, la conduite et l'interpretation des etudes et initiatives de recherche.
Contribuer a l'elaboration des plans de publication, des resumes, affiches et manuscrits destines a des revues a comite de lecture ou a des conferences scientifiques, afin de diffuser les resultats d'etudes et les connaissances scientifiques au sein de la communaute scientifique.
Encadrer et coacher les redacteurs medicaux juniors, en leur fournissant des conseils sur les bonnes pratiques, les techniques de redaction et les principes scientifiques, tout en favorisant une culture d'excellence, de collaboration et d'apprentissage continu au sein de l'equipe de redaction medicale.
Votre profil
Diplome avance en sciences de la vie, pharmacie, medecine ou domaine connexe, avec un minimum de 3 a 5 ans d'experience en redaction medicale au sein de l'industrie pharmaceutique, biotechnologique ou d'une organisation de recherche sous contrat (CRO).
Excellente capacite a interpreter et synthetiser des donnees complexes issues d'essais cliniques, de recherches scientifiques et d'analyses statistiques, avec de solides competences en redaction, relecture et correction, et la capacite a communiquer des concepts scientifiques a des publics varies.
Solide comprehension des exigences reglementaires (par ex. ICH-GCP, FDA, EMA) encadrant la preparation et la soumission des documents et publications cliniques, ainsi qu'une experience dans les interactions avec les autorites reglementaires durant les processus d'examen et d'approbation.
Capacite demontree a travailler efficacement dans un environnement dynamique et exigeant, a gerer plusieurs projets simultanement et a hierarchiser les taches selon les echeances et les livrables.
Excellentes competences interpersonnelles et en communication, avec la capacite de collaborer efficacement avec des equipes pluridisciplinaires, d'etablir des relations avec les parties prenantes cles et d'influencer les processus decisionnels.
Souhaitez-vous que je reformule cette traduction dans un style plus formel et RH (type fiche de poste corporate) ou preferez-vous qu'elle reste fluide et naturelle comme ci-dessus ?
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 maximize 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 to read more about the benefits ICON offers.
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 or submit a request .
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.
Are you a current ICON Employee? Please click to apply

Skills Required