Principal Medical Writer - Home-Based (US/Canada)
- 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 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.
What you will be doing:
- Lead, manage, and coordinate all internal and external writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally.
- Oversee and manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives.
- Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
- Administrate as appropriate, the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents.
- Lead or participate in defining and writing standard operating procedures and working practices which will allow the effective and efficient preparation of quality.
- Lead or participate in cross-functional process improvement initiatives.
- Mentor more junior medical writing staff.
Responsabilités
- Agir en tant que rédacteur médical principal pour de nombreux programmes, projets et études individuelles d’un niveau de complexité modéré à élevé.
- Rédiger et réviser des protocoles/amendements aux protocoles, des synopsis de protocoles, des rapports d’études cliniques, des brochures pour chercheurs (IB)/mises à jour d’IB, des soumissions réglementaires (y compris les composantes cliniques et non cliniques des IND, NDA, BLA, MAA, etc.), et d’autres documents de recherche clinique et/ou de post-marketing. Préparer des manuscrits scientifiques si nécessaire.
- Fournir des conseils en matière de rédaction scientifique et médicale aux clients et aux collègues internes à un niveau de complexité élevé.
- Diriger les équipes de projet dans la rédaction des spécifications des rapports, la rédaction médicale et la coordination des soumissions réglementaires et de l’analyse des données, le cas échéant.
- Servir de mentor actif auprès du personnel à tous les niveaux hiérarchiques.
- Superviser les activités opérationnelles des autres employés en tant que chef d’équipe du projet.
- Élaborer et mettre en œuvre des formations pertinentes.
- Dispenser une formation transversale en cours d’emploi, en interne et pour les clients, dans les domaines d’expertise thérapeutique et/ou technique.
- Participer aux audits externes et internes.
- Fournir des estimations d’offres pour les projets potentiels et assister aux réunions de défense des offres lorsque cela est demandé.
- Agir en tant que membre de groupes d’amélioration des processus et de groupes d’intérêt.
- Participer à d’autres activités non facturables, selon les besoins, et accomplir toute autre tâche jugée appropriée par l’équipe de gestion du département.
You are:
- A Bachelor's degree in a life science discipline, with Master's degree in life science
discipline preferred. - At least 6 years writing experience in the biopharmaceutical/CRO industry required.
- Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.
- Proficiency in organizing and communicating clinical information necessary.
- Strong communications, organizational, time management, and project management skills are required.
- Proficient in MS Word. and experience with template systems (eg, StartingPoint).
- Experience with an electronic document management system (eg, MasterControl,
- Documentum) and use of templates preferred.
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
Qualifications
- Être titulaire d’un diplôme de baccalauréat dans un domaine scientifique, lié à la santé ou au journalisme/à la communication. Diplôme d’études de deuxième ou troisième cycle préférablement.
- Posséder 8 ans d’expérience pertinente ou une combinaison équivalente d’études, de formation et d’expérience pertinente.
- Démontrer d’excellentes compétences en communication écrite et orale et en présentation en anglais américain.
- Posséder de solides compétences dans la rédaction de sections techniques de documents réglementaires et/ou scientifiques, tels que, sans s’y limiter, les protocoles/modifications de protocoles, les synopsis de protocoles, les rapports d’études cliniques, les brochures pour les chercheurs (IB)/les mises à jour des IB, les soumissions réglementaires (y compris les composantes cliniques et non cliniques des IND, NDA, BLA, MAA, etc).
- Accorder une grande importance aux détails.
- Posséder une excellente connaissance des exigences de style énoncées dans le AMA Manual of Style, 10th
- Démontrer des habiletés de haut niveau dans la résolution de problèmes et l’interprétation d’analyses statistiques complexes.
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
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, colour, 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 here.
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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