BridgeBio is hiring: Executive Director, Medical Writing in San Francisco

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you\'re someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we\'ll ask "why not?" and help reengineer the future of biopharma. Affiliate Overview Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You\'ll Do The primary responsibility for this role is to establish and manage the Medical Writing group for the Cardiorenal affiliates (currently includes Eidos Therapeutics and Calcilytix) at BridgeBio. The ideal candidate must have a strong understanding of health authority guidance(s) and requirements for clinical and regulatory documents, including public disclosure requirements in applicable regions. The Senior/Executive Director will be responsible for overseeing the development and finalization of clinical and regulatory documents such as INDs, briefing documents, NDA/MAA summaries, regulatory responses, and key clinical documents (eg, protocols, clinical study reports, investigator brochures). This person will direct, plan, author, and review documents, as well as manage internal and external Medical Writers, for the preparation of high quality documents. Other responsibilities include managing and developing staff to establish strategic, scientific, and technical expertise to support delivery of high-quality documents. Additional oversight of any vendor/contractor leveraged to complete projects. The role requires innovative problem-solving, influencing others, and change-management skills. The Cardiorenal Medical Writing department will support multiple clinical development programs across the Cardiorenal Diseases division of BridgeBio. Currently this includes acoramidis for ATTR (Eidos affiliate) and encaleret for ADH1 (Calcilytix affiliate). The role reports to the VP of Regulatory Affairs. Responsibilities Oversee the Cardiorenal Medical Writing group, including leading, training, and mentoring for effective performance Lead medical writing (including coordination of other Medical Writers) from concept to final product for clinical study protocols and associated forms, protocol amendments, clinical study reports, investigator brochures, and related clinical study documents Provide strategic leadership to study teams to direct the preparation of protocols and CSRs, submissions, and other regulatory documents, and associated public disclosure documents Lead medical writing from concept to final product for regulatory submissions including IND applications, health agency interaction, Meeting Requests, Briefing Documents, NDA/MAA data modules and overall submission packages, and other related documentation for initial and/or supplemental applications for marketing authorization or label expansion Demonstrate in-depth knowledge of regulatory writing and data disclosure requirements Ensure company SOPs related to document development, templates, and medical writing deliverables conform with regulatory requirements (e.g., ICH and other guidelines). Take ownership of processes related to documents and guide teams through these processes Partner with clinical development, biostatistics, and data management in the review and development of tables, figures, and listings (TFLs), and for case narrative planning Work closely with study teams to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other data sources Project manage the document review process, ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed in a timely and efficient manner Ensure documents are generated in accordance with agreed internal processes and standards, are submission-ready, and are appropriately archived in the agreed document management system Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend quality process improvements Establish Medical Writing support models and implement strategies to improve operational efficiencies. Suggest or identify modifications and improvements to document preparation processes and company templates to continuously improve quality, efficiency, and productivity. Apply relevant experience in process initiative and/or vendor management Where You\'ll Work This is a hybrid role and requires in-office collaboration 2-3x per week, or as needed, in our San Francisco, CA & Palo Alto, CA offices. Who You Are Post-graduate scientific or medical degree (eg, MS, MPH, PhD, PharmD, MD, DO) with 10+ years of experience as a regulatory medical writer within the biotechnology or pharmaceutical industry Experienced in medical writing activities for multiple regulatory filings at various development stages Experience managing consultants and their projects Excellent oral and written communication skills, with the ability to summarize and present complex scientific and clinical data effectively with concise, accurate, and clear narrative flow and syntax Proficient in the drug development process, and strong understanding of health authority regulations, ICH guidelines, and medical writing standards, with the ability to interpret and apply these to document writing Excellent interpersonal, active listening, and influencing skills Strong project management skills, ability to work independently, multi-task, and work effectively under pressure Experience with EndNote, StartingPoint templates, and Veeva Vault preferred Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Referral program with $2,500 award for hired referrals Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office Skill Development & Career Paths: People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. $260,000 - $300,000 USD Are you legally authorized to work in the United States? * If hired by BridgeBio or one of its affiliates, will you now or in the future require sponsorship for employment visa status (e.g. H-1B, TN, OPT, etc)? * How did you hear about us? * Are you open to relocating to the San Francisco Bay Area? * U.S. Standard Demographic Questions We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process. #J-18808-Ljbffr In Summary: The Senior/Executive Director will be responsible for overseeing the development and finalization of clinical and regulatory documents such as INDs, briefing documents, NDA/MAA summaries, regulatory responses, and key clinical documents . He will direct, plan, author, and review documents, as well as manage internal and external Medical Writers . The role requires innovative problem-solving, influencing others, and change-management skills . En Español: ¿Cuándo fue la última vez que logró lo imposible? Si ese pensamiento se siente abrumador, tal vez quieras hacer una pausa aquí, pero si despierta emoción...leer en 2015 iniciamos un moneyball para el enfoque de biotecnología, reunificando proyectos y prometiendo investigaciones iniciales del mundo académico juntos bajo un mismo paraguas financiero para reducir riesgos y desencadenar innovación. Este modelo permite a ciencia y pequeños equipos de expertos liderar el camino. Construimos puentes hacia avances innovadores en enfermedades raras, y desarrollamos medicamentos que cambian la vida de los pacientes con necesidades insatisfechas tan rápido como sea humanamente posible. Juntos definimos espacio blanco, fronteras y empoderamos a las personas para resolver problemas. El Director Senior/Ejecutivo será responsable de supervisar el desarrollo y finalización de documentos clínicos y regulatorios como IND, documentos informativos, resúmenes NDA / MAA, respuestas reglamentarias y documentos clínicas clave (por ejemplo, protocolos, informes de estudios clínicos, folletos investigadores). Esta persona dirigirá, planeará, escribirá y revisará los documentos, así como administrará a Escritores Médicos Internos y Exteriores para la preparación de documentos de alta calidad. Otras responsabilidades incluyen gestionar y desarrollar personal para establecer experiencia estratégica, científica y técnica para apoyar la entrega de documentaciones de alta calidad. Supervisión adicional de cualquier proveedor / contratista aprovechado para completar proyectos. Responsabilidades Supervisar el grupo de redacción médica cardiorenal, incluido dirigir, capacitar y asesorar para un rendimiento efectivo Dirigir la escritura médica (incluida la coordinación de otros Escritores Médicos) desde el concepto hasta el producto final para los protocolos de estudio clínico y formularios asociados, enmiendas al protocolo, informes de estudios clínicos, folletos del investigador y documentos relacionados con el estudio clínicamente Proporcionar liderazgo estratégico a los equipos de estudio para orientar la preparación de protocolos y CSRs, presentaciones y otros documentos regulatorios, y documentos de divulgación pública asociados Direccionar la escrituría médica de conceptos a productos finales para las presentaciones reguladoras incluyendo solicitudes INDDA, interacción de agencias sanitarias, Solicitudes de reuniones, Documentos informativos, módulos de datos NULES/MAA y paquetes generales de presentación, y otras aplicaciones relacionadas para la autorización de comercialización o expansión Demonstrar conocimientos en materia de documentación reglamentaria y requisitos de desarrollo de etiquetas médicas e indicadores médicos. Asumir la propiedad de los procesos relacionados con documentos y equipos guía a través de estos procesos Colaborar con el desarrollo clínico, biostatisticas y gestión de datos en la revisión y elaboración de tablas, cifras y listas (TFLs) y para la planificación narrativa de casos Trabajar estrechamente con equipos de estudio para garantizar que los resultados y mensajes en documentos clínicos reflejen correctamente los datos en TFLs y otras fuentes de datos Proyecto gestionar el proceso de revisión de documentos, asegurando que se aclaran y aborden adecuadamente las observaciones contradictorias y/o ambiguas de una manera oportuna y eficiente Asegurarse de que los documentos sean elaborados de acuerdo con los estándares internos y acordados, estén listos para su presentación y estén debidamente archivados en el sistema de administración de documentos convenido Asegurarse de que se realicen verificaciones apropiadas de control documentado de calidad (QC) sobre la escritura médica, encontrar pruebas y mejorar la calidad del proceso Establishing the Quality Management Processes. ¿Quién eres Licenciado en Ciencia o Medicina (por ejemplo, MS, MPH, PhD, PharmD, MD, DO) con más de 10 años de experiencia como redactor médico regulador dentro de la industria biotecnológica o farmacéutica Experiencia en actividades de escritura médica para múltiples presentaciones regulatorias en varias etapas de desarrollo Experiencia administrando consultores y sus proyectos Excelentes habilidades de comunicación oral y escrita, con capacidad de resumir y presentar datos científicos y clínicos complejos eficazmente con flujo narrativo y sintaxis concisa, precisa y clara Proficiente en el proceso de desarrollo de fármacos, y una sólida comprensión de las normativas de autoridad sanitaria, directrices ICH y estándares médicos, con la capacidad de interpretar y aplicar estos para documentar excelentes habilidad interpersonal, escucha activa e influencias Habilidades de gestión del proyecto Fuertes habilidades, capacidad de trabajar de forma independiente, tarea, y trabajo bajo presión múltiple. Compensación líder del mercado 401K con 100% partido de empleador en el primer 3% y 50% en el siguiente 2% Programa de compra de acciones de los empleados Programa de referencia con $2,500 premio para las referencias contratadas Atención médica integral con primas al 100% cubiertas - sin costo para usted y dependientes Soporte mental a través de Spring Health (6 sesiones terapéuticas & 6 sesiones de coaching) Modelo de trabajo híbrido - Los empleados tienen la autonomía en dónde y cómo hacen su trabajo Tiempo libre flexible ilimitado - Tómese el tiempo que necesite licencia parental pagada - 4 meses para padres nacidos y 2 meses para los padres no nacidos Cuentas de gasto flexibles y un almuerzo subsidiado por parte de la compañía via Forkable en días desde nuestra oficina Desarrollo de habilidades y caminos profesionales: Las personas son parte de una historia de crecimiento y éxito - desde el descubrimiento profesional hasta pruebas laborales y tuberías de salud, ofrecemos oportunidades de desarrollo activo e inmobiliario. El salario final ofrecido a un candidato exitoso dependerá de varios factores que pueden incluir pero no se limitan al tipo y duración de la experiencia dentro del trabajo, el tipo y la longitud de experiencia en la industria, antecedentes educativos, ubicación de residencia y rendimiento durante el proceso de entrevista. BridgeBio es un empleador multiestado, y este rango de salarios puede no reflejar posiciones basadas en otros estados. $260,000 - $300,000 USD ¿Estás legalmente autorizado para trabajar en los Estados Unidos? * Si eres contratado por BridgeBIO o una de sus afiliados, necesitarás ahora o en el futuro patrocinio para obtener visas de empleo (por ejemplo H-1B, TN, OPT, etc.)