Remote Sr Medical Writer- Regulatory Strategy Writing
- Canada, United States
- Medical Writing
- ICON Strategic Solutions
- Remote
TA Business Specialist
- Icon Strategic Solutions
About the role
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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Regulatory Strategic Writing (RSW) Senior Writer is responsible for providing support to one or more Therapeutic Areas (TA) as designated by RSW leadership. The Senior Writer provides support for the preparation and submission of critical regulatory documents (e.g., briefing books) and responses to health authority information requests using available reference materials such as documentation of previous interactions with healthcare authorities, clinical development documentation, scientific literature, and content provided by Global Regulatory Product Team (GRPT) team members. The Senior Writer is also responsible for ensuring the accuracy and quality of submission-ready documents using established RSW writing processes. The Senior Writer partners with the RSW TA lead, other RSW contributing staff, as well as the Global Regulatory Lead/Area Regulatory Lead to prepare high-quality, accurate and concise
documentation supporting the objectives of GRPT teams and leadership.
Responsibilities:
- Prepare, write, edit, and review high-quality, clearly-messaged documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities. When necessary,
serve as the RSW representative on project teams with the GRPT members, and functional area contributors (e.g., Clinical, Pharmacovigilance, CPPM, etc.) and other RSW staff. - Participate in project management for compound programs and/or RSW projects and initiatives. Ensure accurate and timely completion/delivery of information and review of regulatory submissions. Communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members. In pursuit of this responsibility the Senior Writer is to work closely with GRPT members on the strategic content of target documents.
- Understand, assimilate, and interpret sources of information (e.g., scientific literature, internal and external studies, research documentation, charts, graphs, and tables, and previous interactions with healthcare authorities) with appropriate guidance/direction from GRPT team and/or authors/key opinion leaders. Ensure required documentation is obtained. Explain and prepare data in a manner consistent with regulatory requirements. Confirm quality and completeness of information to be presented. Challenge conclusions when necessary. Convert relevant data and information into a form that meets regulatory document requirements. Ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.
- Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents.
- Assist in the arrangement and conduct of review meetings with the team.
- Resolve document content issues and questions arising during the writing process.
- Assist with regular communication with RSW leadership on timeline/milestone progress for any assigned program. Assess resource needs as timelines progress and communicate any additional resource requests to the manager.
- Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs.
- Assist in the design and implementation of tactical process improvements.
- A bachelor's degree is required , either a Bachelor of Science, with significant relevant writing experience, or Bachelor of Arts in English or Communications with significant relevant science experience. A relevant advanced degree (e.g., MS, PharmD, PhD, MD) is preferred, and higher education may substitute for years of experience. American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.
- Minimum of 2 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia, or in a related area such as quality, regulatory, clinical research, or product support/R&D.
- High-level content writing experience and experience with clinical development regulatory documents preferred, with working knowledge of statistical concepts and techniques. Excellent written and oral communication skills. Capable of assimilating and interpreting scientific content with adeptness in ability to translate for appropriate audience. Excellent attention to detail and superior ability with respect to consistency, clarity and accuracy.
- Knowledge of US and international regulations, requirements and guidance associated with regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
- Knowledge of Common Technical Document content templates, electronic document management systems and information technology.
Excellent working knowledge of software programs in Windows environment.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.
Le rédacteur senior du service de la rédaction stratégique réglementaire (RSR) est chargé de fournir un soutien à un ou plusieurs domaines thérapeutiques (DT) désignés par la direction de la RSR. Le rédacteur senior fournit son soutien dans la préparation et la soumission de documents réglementaires critiques (p. ex. des dossiers de synthèse) et les réponses aux demandes d’informations des autorités sanitaires en se reportant aux documents de référence disponibles comme la documentation relative aux interactions antérieures avec les autorités sanitaires, la documentation sur le développement clinique, la documentation scientifique et le contenu fourni par les membres de l’équipe mondiale de la réglementation des produits (EMRP). Le rédacteur senior est également chargé d’assurer l’exactitude et la qualité des documents prêts à être soumis en utilisant les processus de rédaction établis pour la RSR. Le rédacteur senior agit en partenariat avec la direction des DT de la RSR, d’autre personnel contribuant à la RSR, ainsi qu’avec la direction de la réglementation à l’échelle mondiale/direction de la réglementation à l’échelle régionale dans la préparation d’une documentation de haute qualité, exacte et concise en appui aux objectifs des équipes et de la direction de l’EMPR.
Responsabilités :
Préparer, rédiger, éditer et réviser des documents de haute qualité communiquant des messages clairs fondés sur la réglementation et scientifiquement fondés pour les soumettre aux agences de réglementation et aux autorités sanitaires. Si nécessaire, servir de représentant de la RSR dans les équipes de projet avec les membres de l’EMRP et les contributeurs des domaines fonctionnels (p. ex. services cliniques, de pharmacovigilance, de pharmacologie clinique et de pharmacométrie, etc.) et d’autres membres du personnel de la RSR.
Participer à la gestion de projet pour les programmes composés et/ou les projets et initiatives de la RSR. Veiller à ce que les informations soient complétées/livrées de manière précise et en temps opportun et examiner les soumissions réglementaires. Communiquer aux membres de l’équipe les livrables nécessaires, leurs processus d’écriture correspondants, les échéanciers et les étapes du projet. Dans les efforts déployés pour assumer cette responsabilité, le rédacteur senior doit travailler en étroite collaboration avec les membres de l’EMPR sur le contenu stratégique des documents cibles.
Comprendre, assimiler et interpréter de manière productive les sources d’information (p. ex. la documentation scientifique, les études en interne et en externe, la documentation de recherche, les diagrammes, les graphiques, les tableaux, et les interactions antérieures avec les autorités sanitaires) en suivant les conseils/directives appropriés de l’EMPR et/ou des auteurs ou principaux leaders d’opinion. S’assurer d’obtenir la documentation requise est obtenue. Expliquer et préparer les données conformément aux exigences réglementaires. Vérifier la qualité et l’exhaustivité des informations à présenter. Remettre en question les conclusions si nécessaire. Convertir les données et informations pertinentes en un formulaire qui répond aux exigences concernant les documents réglementaires. S’assurer que tous les livrables des documents électroniques réglementaires sont traités et compilés conformément aux échéanciers.
Aider à la coordination de l’examen, l’approbation, le contrôle de la qualité (CQ) et d’autres fonctions appropriées impliquées dans la production de documents réglementaires.
Aider à l’organisation et à la direction des réunions d’examen avec l’équipe.
Résoudre les problèmes de contenu du document et les questions soulevées au cours du processus de rédaction.
Communiquer régulièrement avec la direction de la RSW pour l’informer de la progression relativement à l’échéancier et aux étapes franchies pour tout programme assigné. Évaluer les besoins en ressources au fur et à mesure de l’avancement dans les échéanciers et communiquer toute demande de ressources supplémentaires à la direction du service.
Comprendre/respecter les conventions appropriées, l’utilisation correcte de la grammaire et les bonnes exigences de format selon la CIH et d’autres organes directeurs en suivant les directives, les modèles et les PON applicables de la division.
Aider à la conception et à la mise en œuvre des améliorations au processus stratégique.
Un diplôme de baccalauréat est requis, soit un diplôme de baccalauréat ès sciences avec une solide expérience pertinente en rédaction, ou un diplôme de baccalauréat ès arts en anglais ou en communication avec une solide expérience pertinente dans le domaine scientifique. Un diplôme supérieur pertinent (p. ex. M. Sc., Pharm. D., Ph. D., M.D.) est préféré et des années d’études supérieures peuvent compenser des années d’expérience manquantes. Une certification de l’American Medical Writing Association (AMWA) ou autre est préférable, avec une spécialité en rédaction pharmaceutique.
Minimum de 2 ans d’expérience pertinente dans l’industrie en rédaction médicale/réglementaire dans l’industrie de la santé ou dans le milieu universitaire requis, ou dans un domaine connexe comme la qualité, la réglementation, la recherche clinique ou le soutien au produit ou la R&D.
Expérience en rédaction de contenu de haut niveau et expérience avec les documents réglementaires de développement clinique requis, incluant une connaissance pratique des concepts et des techniques statistiques. Excellentes compétences en communication écrite et orale. Capacité à assimiler et interpréter le contenu scientifique avec une aptitude avérée à l’adapter au public concerné. Excellent souci du détail et capacité supérieure en matière de cohérence, de clarté et de précision.
Connaissance des réglementations américaines et internationales, des exigences et des directives associées à la préparation et à la soumission de documents réglementaires et capacité à conseiller les équipes concernant la conformité aux réglementations.
Connaissance des modèles de contenu de documents techniques communs, des systèmes de gestion de documents électroniques et des technologies de l’information.
Excellente connaissance pratique des logiciels dans l’environnement Windows.
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