Senior Regulatory Medical Writer Job at Frey Consulting Group in San Rafael

Seeking candidates who are regulatory medical writers (not Medical Communication). The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications. Responsibilities: Drafts and edits documents used for submissions including CTDs and RtQs. Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms. Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PSURs, DSURs, etc.). Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes. Adheres to departmental procedures and practices and technical and industry standards during all aspects of work. Works effectively with cross-functional groups within the company. Other tasks as assigned. Skills: Fulfills one of the following: Medical writer in the pharmaceutical industry. Medical or scientific writing experience as a primary job responsibility. Skill and Experience: At least 6+ years experience required. Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies. Familiar with clinical study data collection and results reporting. Experience writing, reviewing, or editing protocols and clinical study reports highly preferred. Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred. Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content. Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals. Ability to interpret basic tabular and graphical clinical data presentations. Ability to create basic tables using AMA style (eg, Schedule of Events). Intermediate applied knowledge of basic clinical laboratory tests. Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Basic understanding of biostatistical and clinical research concepts. Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint. Experienced with scanners, printers, and copiers. Basic knowledge of regulatory requirements and guidances associated with 'standalone' regulatory documents (eg, protocols, investigator brochures, and clinical study reports). Capable of working on multiple tasks and shifting priorities. Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation. Motivated and shows initiative. Detail oriented. Capable of well organized, concise and clear written and verbal communication. Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements. Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills. Education: Bachelor's or higher degree; scientific focus desirable. Evidence of medical writing career development desirable, eg, American or European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association. The hiring range for this position is $61to $71 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class. #J-18808-Ljbffr In Summary: Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies . Responsibilities: Drafts and edits documents used for submissions including CTDs and RtQs . Adheres to departmental procedures and practices and technical and industry standards . En Español: Buscar candidatos que sean escritores médicos reguladores (no Comunicación Médica). El Escritor Médico de Contrato aplica habilidades avanzadas para la preparación de documentación y gestión del proyecto de documentos para ayudar en el desarrollo, redacción, revisión, edición y finalización de los documentos utilizados para llevar a cabo estudios clínicos e informes sobre resultados de estudio clínico para presentaciones y publicaciones regulatorias. Responsabilidades: Drafting and editing documents used for submissions including CTDs and RtQs. Familiar con el proceso de desarrollo de fármacos (descubrimiento al mercado), diseño y conducción del protocolo de estudio clínico, así como la documentación necesaria para llevar a cabo estudios clínicos. familiarizado con la recopilación de datos de los estudios médicos e información sobre resultados. Experiencia en escribir, revisar o editar protocolos y informes de estudios clíticos es muy preferible. Capaz de liderar un equipo transversal bajo cronogramas estrictos, incluyendo convocar reuniones y ejecutar reuniones e administrar las etapas de revisión del equipo y la adjudicación de comentarios en la preparación de documentos. Motivado y muestra iniciativa. orientado al detalle. Capacidad para una comunicación escrita y verbal bien organizada, concisa y clara. Capable de comprender conceptos científicos complejos y traducirlos a texto claro, conciso y apropiadamente referenciado que cumpla con los requisitos regulatorios. Eficaz en explicar principios de escritura a una audiencia variada tanto en entornos individuales como grupales; habilidades básicas de presentación. Educación: Licenciatura o más alta; enfoque científico deseable. Prueba de desarrollo profesional de redacción médica deseable, por ejemplo, Asociación Americana o Europea de Escritores, certificado en Vida o capacitación relevante a través de Asociación Médica de Información. El rango de contratación para este puesto es de $61 a 71 dólares por hora. Todos los solicitantes calificados recibirán una consideración para el empleo sin tener en cuenta la raza, color, religión, género, identidad o expresión de sexo, orientación sexual, origen nacional, genética, embarazo, discapacidad, edad, estatus de veterano u otra clase protegida federal, estatal o local. #J-18808-Ljbffr