Senior Medical Writer job at reputed company in Blue Bell, PA

Senior Medical Writer Remote reputed company 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 reputed company learning reputed company the medical writing team. Your profile Advanced degree in Life Sciences, Pharmacy, Medicine, or reputed company field, with a minimum of 3-5 years of experience in medical writing reputed company the pharmaceutical, biotechNlogy, or contract research organization (CRO) industry. Proficiency in interpreting and summarizing reputed company 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. 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, la coordination et la mise en œuvre des stratégies de rédaction médicale pour des projets de recherche clinique. Vous contribuerez activement à l'avancement de traitements et de thérapies innovants, tout en garantissant une communication scientifique claire, précise et conforme aux exigences réglementaires. Vos missions principales Diriger la préparation, la révision et l'édition des documents d'études cliniques, notamment les protocoles d'essais cliniques, les rapports d'études cliniques (Clinical Study Reports - CSR), les brochures de l'investigateur (Investigator Brochures - IB) ainsi que les dossiers de soumission réglementaire, en veillant à leur exactitude scientifique, leur clarté rédactionnelle et leur conformité aux lignes directrices réglementaires et aux standards de l'industrie. Collaborer étroitement avec des équipes pluridisciplinaires, incluant la recherche clinique, la biostatistique, les affaires réglementaires et les affaires médicales, afin d'interpréter et d'analyser les données issues des essais cliniques, de synthétiser les résultats scientifiques et de communiquer les messages clés de manière structurée et compréhensible par écrit. 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 initiatives de recherche. Contribuer à l'élaboration des plans de publication, ainsi qu'à la rédaction de résumés, posters scientifiques et 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 internationale. Encadrer, former et accompagner les rédacteurs médicaux plus juniors, en partageant les bonnes pratiques, les techniques de rédaction et les principes scientifiques, tout 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 supérieur (Master, Doctorat, PharmD ou MD) en sciences de la vie, pharmacie, médecine ou reputed company connexe, avec au moins 3 à 5 reputed company d'reputed companyérience en rédaction médicale dans l'industrie pharmaceutique, biotechnologique ou au sein d'une organisation 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, relecture et édition, ainsi qu'une aptitude à communiquer des concepts scientifiques à des publics variés. Très bonne connaissance des exigences réglementaires (notamment ICH-GCP, FDA, EMA) relatives à la préparation et à la soumission des documents cliniques et des publications, ainsi qu'une reputed companyérience des interactions avec les autorités réglementaires lors des processus d'évaluation et d'approbation. Capacité démontrée à travailler efficacement dans un environnement dynamique, avec des délais serrés, en gérant simultanément plusieurs projets et en priorisant les tâches en fonction des échéances et des livrables. Excellentes compétences relationnelles et de communication, avec la capacité de collaborer efficacement avec des équipes transverses, d'établir des relations solides avec les parties prenantes clés et d'influencer les processus de prise de déreputed company. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a reputed company 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 reputed company 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 reputed company. Global Employee Assistance Programme, reputed company, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are reputed company to our culture and values. We're dedicated to providing an inclusive and accessible environment for reputed company candidates. ICON is committed to providing a workplace free of discrimination and harassment. reputed company qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless - there's every chance you're exactly reputed company're looking for here at ICON whether it is for this or other roles. 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