Senior Medical Writer – Clinical Focus

🔥 il y a 8 heures

🌐 États-Unis, Canada – Distant

🇺🇸 États-Unis – Télétravail 🇨🇦 Canada – Télétravail

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

💵 $116 000 - $128 000 / an

⏰ Temps Plein

🟠 Senior

🏥📝 Rédacteur Médical

🦅 Parrain de Visa H1B

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Veristat

Site WebLinkedInTous les Emplois

501 - 1000 employés

💼 Conseil

🏥 Santé

💊 Pharmaceutique

💰 Private equity en 2021-05

Consulting • Healthcare • Pharmaceuticals

Veristat est une société de services de développement clinique qui offre un soutien complet et axé sur la réglementation pour les promoteurs de produits biopharmaceutiques et de dispositifs médicaux. L'entreprise propose des services complets de planification et de conduite d'essais cliniques, des affaires réglementaires et un soutien aux soumissions (y compris NDA/MAA et les interactions avec des agences comme la PMDA), des services statistiques et de biométrie, de rédaction médicale, de pharmacovigilance, et de gestion de projet pour des domaines thérapeutiques complexes tels que l'oncologie, les maladies rares, la neurologie, les produits biologiques, et les thérapies cellulaires et géniques. Veristat opère en tant que partenaire B2B pour les organisations biotechnologiques et pharmaceutiques afin de réduire le risque de développement et d'accélérer l'approbation réglementaire.

Description

• Contribute to authorship of a variety of documents across different service lines • Lead smaller projects as project lead and interface directly with clients • Support larger, more complex engagements as a member of a larger delivery team • Use clinical regulatory writing expertise to lead teams and help clients achieve their goals • Understand regulatory authority guidelines and requirements • Anticipate how writing practice conventions affect final products submitted for health authority approval or acceptance • Develop submission-level documents • Develop clinical documents such as Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE • Synthesize data across multiple data sources and documents to create summary reports • Conduct or lead a CRM and lead project teams to consensus • Present ideas and suggestions using logical arguments and respond positively to opposing views • Develop professional client relationships and maintain current industry knowledge • Identify and institutionalize effective work practices to ensure consistency in performance

🎯 Exigences

• Bachelor’s degree or higher in a scientific discipline strongly preferred • 3+ years of regulatory writing experience or equivalent experience with clinical-related documentation • Understanding of regulatory authority guidelines and requirements • Experience developing submission-level documents • Experience developing clinical documents such as Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE • Intermediate proficiency with Microsoft Word, including editing tools, creating and modifying tables, and inserting figures • Knowledge of document management techniques • Strong understanding of the document creation process and drug development lifecycle • Ability to synthesize data across multiple data sources and documents • Ability to conduct or lead a CRM • Ability to lead a project team to consensus • Ability to use logical arguments to persuade others and respond positively to opposing views • Ability to develop professional relationships with clients • Ability to identify and institutionalize effective work practices

🏖️ Avantages

• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans • Applicable bonus • Equal employment opportunities • Reasonable accommodations for the application, assessment, or interview process