Lead Medical Writer – Magazica Career Hub

Title: Lead Medical Writer

Company: ICON
Location: Burlington, Ontario
Job Type: FlexTime, FullTime

Description:

ICON plc is seeking a Senior Medical Writer to join their team. The role involves leading the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies.

Key Responsibilities:

Leading the preparation, review, and editing of clinical study documents

Collaborating with cross-functional teams to interpret and analyze clinical trial data

Participating in the planning and execution of clinical development programs

Contributing to the development of publication plans

Mentoring and coaching junior medical writers

Qualifications:

Advanced degree in Life Sciences, Pharmacy, Medicine, or related field

3-5 years of experience in medical writing

Proficiency in interpreting and summarizing complex clinical trial data

Strong understanding of regulatory requirements

Excellent interpersonal and communication skills

ICON offers competitive salaries and a range of benefits focused on well-being and work-life balance. They are committed to creating an inclusive and accessible environment for all candidates. Interested applicants are encouraged to apply, even if they don't meet all requirements.

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Title: Lead Medical Writer
Company: ICON
Location: Burlington, Ontario
Senior Medical Writer RemoteICON plc is a worldleading 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 developmentWe 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 innovative 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 crossfunctional 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 peerreviewed 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 35 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., ICHGCP, 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 fastpaced, deadlinedriven 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 crossfunctional teams, build relationships with key stakeholders, and influence decisionmaking processes.

Nous recherchons actuellement un(e) Rédacteur(trice) Médical(e) Senior pour rejoindre notre équipe diversifiée et dynamique. En tant que Rédacteur(trice) Médical(e) Senior chez ICON, vous jouerez un rôle clé dans la définition et la mise en œuvre des stratégies de rédaction médicale pour les projets de recherche clinique, contribuant ainsi au développement de traitements et de thérapies innovants.Vos missions Piloter la préparation, la revue et l'édition des documents d'études cliniques, notamment les protocoles d'études cliniques, les rapports d'études cliniques (CSR), les brochures investigateur (IB) et les dossiers réglementaires, en garantissant leur exactitude, leur clarté et leur conformité aux exigences réglementaires et aux standards de l'industrie.Collaborer étroitement avec des équipes transverses (recherche clinique, biostatistiques, affaires réglementaires, affaires médicales) afin d'interpréter et d'analyser les données d'essais cliniques, de synthétiser les résultats scientifiques et de communiquer les informations clés sous forme écrite.Participer à la planification et à l'exécution des programmes de développement clinique, en apportant une contribution stratégique et une expertise scientifique pour soutenir la conception, la conduite et l'interprétation des études cliniques et des projets de recherche.Contribuer à l'élaboration de plans de publication, de résumés, de posters et de manuscrits destinés à des revues à comité de lecture et à des congrès scientifiques, afin de diffuser les résultats des études et les connaissances scientifiques auprès de la communauté scientifique.Encadrer et accompagner les rédacteurs médicaux juniors, en leur fournissant des conseils sur les bonnes pratiques, les techniques de rédaction et les principes scientifiques, et en favorisant une culture d'excellence, de collaboration et d'apprentissage continu au sein de l'équipe de rédaction médicale.Votre profil Diplôme de niveau avancé en sciences de la vie, pharmacie, médecine ou domaine connexe, avec au moins 3 à 5 ans d'expérience en rédaction médicale au sein de l'industrie pharmaceutique, biotechnologique ou d'une société de recherche sous contrat (CRO).Excellente capacité à interpréter et synthétiser des données complexes d'essais cliniques, des résultats de recherche scientifique et des analyses statistiques, avec de solides compétences en rédaction, édition et relecture, et une aptitude à communiquer des concepts scientifiques à des publics variés.Bonne connaissance des exigences réglementaires (par ex. ICHGCP, FDA, EMA) encadrant la préparation et la soumission des documents cliniques et des publications, ainsi qu'une expérience des interactions avec les autorités réglementaires lors des processus de revue et d'approbation.Capacité démontrée à travailler efficacement dans un environnement dynamique et exigeant en termes de délais, en gérant plusieurs projets simultanément et en priorisant les tâches selon les échéances et les livrables.Excellentes compétences relationnelles et de communication, avec la capacité de collaborer efficacement avec des équipes transverses, de développer des relations avec les parties prenantes clés et d'influencer les processus décisionnels.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 wellbeing and work life balance opportunities for you and your family.Our benefits examples include:Various annual leave entitlementsA 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 24hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's wellbeing.Life assuranceFlexible countryspecific 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 &amp; 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

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