Principal Medical Writer

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Responsibilities

• Acts as a lead medical writer on numerous programs, projects and individual studies at a moderate to complex level.
• Writes and reviews protocols/protocol amendments, protocol synopses, clinical study reports, investigator brochures (IBs)/IB updates, regulatory submissions (including clinical and nonclinical components of INDs, NDAs, BLAs, MAAs, etc), and other clinical research and/or post-marketing documents. Prepares scientific manuscripts when required.
• Provides scientific and medical writing consultancy to clients and internal colleagues at a complex level.
• Leads project teams in drafting report specifications, medical writing, and coordination of regulatory submissions and data analysis, where required.
• Serves as an active mentor to all levels of personnel.
• Oversees operational activities of other staff as the project team leader.
• Develops and implements relevant training.
• Conducts in-service cross functional training internally and for clients in areas of therapeutic and/or technical expertise.
• Participates in external and internal audits.
• Provides bid estimates for potential projects and attends bid defense meetings when requested.
• Acts as a member of process improvement and interest groups.
• Participates in other non-billable activities as required and performs any other tasks deemed appropriate by the department management team.

Qualifications

• Has Bachelor’s degree in scientific, health-related or journalism/ communications field. Graduate/advanced degree preferred.
• Has 8 years of relevant experience or equivalent combination of education, training, and relevant experience.
• Exhibits excellent written and oral communication and presentation skills in American English.
• Has substantial skill in writing technical sections of regulatory and/or scientific documents, such as but not limited to protocols/protocol amendments, protocol synopses, clinical study reports, investigator brochures (IBs)/IB updates, regulatory submissions (including clinical and nonclinical components of INDs, NDAs, BLAs, MAAs, etc).
• Possesses strong attention to detail.
• Has excellent knowledge of style requirements set forth in the AMA Manual of Style, 10th edition.
• Demonstrates sophisticated level of problem solving and interpretation of complex statistical analyses.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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 through the form below.

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.

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 edition.
• Démontrer des habiletés de haut niveau dans la résolution de problèmes et l’interprétation d’analyses statistiques complexes.

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