Medical Writing Contractor Job at Aequor Inc in New York

Medical Writing Contractor 100% REMOTE WORK
Position Summary: The Medical Writing Contractor is accountable for the timely delivery of high quality, regulatory-compliant documents including but not limited to protocols, IBs, clinical study reports, health authority briefing books and clinical summary documents for assigned program and ensures documents are delivered per corporate objectives, from planning through internal approval.
Responsibilities and Duties: Responsible for the development of high quality clinical documents submitted to Regulatory Authorities (e.g. FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions.
Collaborates with Global Development Teams and Clinical Development to ensure alignment with program objectives.
Oversees and reviews medical writing deliverables assigned to contractors or other third party vendors.
Participates in Global Medical Writing initiatives on clinical development cross-functional teams.
Assists with development and implementation of Medical Writing processes improvement in line with SOPs.
Owns and updates assigned Medical Writing SOPs, as necessary.
Educational Requirements: Bachelor's Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred.
Experience: Minimum of 5 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
Previous experience in Medical Writing in clinical drug development, preferably some experience in Oncology.
Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
Knowledge of template development, document management systems and requirements.
Strong working knowledge of Medical Writing requirements and document components.
Good interpersonal skills that involves working well in a team environment and the ability to lead others.
Strong PC skills including Medical Writing software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint (and any additional software packages utilized).

In Summary: The Medical Writing Contractor is accountable for the timely delivery of high quality, regulatory-compliant documents . Responsible for the development of . high quality clinical documents submitted to Regulatory Authorities (e.g. FDA and EMA) The Contractor ensures documents are delivered per corporate objectives, from planning through internal approval .

En Español: Contratista de escritura médica 100% REMOTE WORK Posición Resumen: El contratista de redacción médica es responsable de la entrega oportuna de documentos clínicos de alta calidad presentados a las autoridades reguladoras (por ejemplo, FDA y EMA), incluidos pero no limitados a los protocolos, IBs, informes de estudios clínicos, libros informativos de la autoridad sanitaria y documentos sumarios clínicos para el programa asignado y asegura que se entreguen los documentos por objetivos corporativos, desde la planificación hasta la aprobación interna. Responsabilidades y deberes: Responsable del desarrollo de documentación clínica de alta cualidad enviada a las Autoridades Reguladoras (como la FDA y la EMA) incluyendo Informes sobre Estudios Clínicos, Brochures de Investigadores, Protocolos, Enmiendas de Protocolo, Documentos Briefing Owning, respuestas de la Autoridad Sanitaria, y secciones Sumarias Técnicas Comúnes (CTDs) en Asia (extractores de asesoramiento clínico). Grado avanzado preferido. Experiencia: Un mínimo de 5 años de experiencia combinada en la configuración académica/clínica y/o industrial para escribir protocolos clínicos, CSRs y / o documentos médicos y / u científicos. Experiencias previas en escritura médica en el desarrollo clínico de medicamentos, preferiblemente alguna experiencia en oncología. Familiarización con el proceso de presentación regulador, las pautas ICH y GCP y recomendaciones. Conocimiento del desarrollo de plantillas, sistemas de gestión de documentos y requisitos. Fuertes conocimientos laborales de los requerimientos de redacción médica y componentes de documentos. Buenas habilidades interpersonales que implican trabajar bien en un entorno de equipo y la capacidad de liderar a otros.