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Form of workICON 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.
Responsibilities- 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.
Responsabilites
- Agir en tant que redacteur medical principal pour de nombreux programmes, projets et etudes individuelles d'un niveau de complexite modere a eleve.
- Rediger et reviser des protocoles/amendements aux protocoles, des synopsis de protocoles, des rapports d'etudes cliniques, des brochures pour chercheurs (IB)/mises a jour d'IB, des soumissions reglementaires (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. Preparer des manuscrits scientifiques si necessaire.
- Fournir des conseils en matiere de redaction scientifique et medicale aux clients et aux collegues internes a un niveau de complexite eleve.
- Diriger les equipes de projet dans la redaction des specifications des rapports, la redaction medicale et la coordination des soumissions reglementaires et de l'analyse des donnees, le cas echeant.
- Servir de mentor actif aupres du personnel a tous les niveaux hierarchiques.
- Superviser les activites operationnelles des autres employes en tant que chef d'equipe du projet.
- Elaborer et mettre en uvre des formations pertinentes.
- Dispenser une formation transversale en cours d'emploi, en interne et pour les clients, dans les domaines d'expertise therapeutique et/ou technique.
- Participer aux audits externes et internes.
- Fournir des estimations d'offres pour les projets potentiels et assister aux reunions de defense des offres lorsque cela est demande.
- Agir en tant que membre de groupes d'amelioration des processus et de groupes d'interet.
- Participer a d'autres activites non facturables, selon les besoins, et accomplir toute autre tache jugee appropriee par l'equipe de gestion du departement.
- A Bachelor's degree in a life science discipline, with Master's degree in life sciencediscipline 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
- Etre titulaire d'un diplome de baccalaureat dans un domaine scientifique, lie a la sante ou au journalisme/a la communication. Diplome d'etudes de deuxieme ou troisieme cycle preferablement.
- Posseder 8 ans d'experience pertinente ou une combinaison equivalente d'etudes, de formation et d'experience pertinente.
- Demontrer d'excellentes competences en communication ecrite et orale et en presentation en anglais americain.
- Posseder de solides competences dans la redaction de sections techniques de documents reglementaires et/ou scientifiques, tels que, sans s'y limiter, les protocoles/modifications de protocoles, les synopsis de protocoles, les rapports d'etudes cliniques, les brochures pour les chercheurs (IB)/les mises a jour des IB, les soumissions reglementaires (y compris les composantes cliniques et non cliniques des IND, NDA, BLA, MAA, etc).
- Accorder une grande importance aux details.
- Posseder une excellente connaissance des exigences de style enoncees dans le AMA Manual of Style, 10th
- Demontrer des habiletes de haut niveau dans la resolution de problemes et l'interpretation 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/benefitsICON, 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.
Employment Type: OTHER
