BioMarin Pharmaceutical Inc. is hiring: Medical Writer in San Rafael
BioMarin Pharmaceutical Inc., San Rafael, CA, United States
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
The Medical Writer 1 applies basic to intermediate 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 in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.)
Aids in managing 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
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Assists in developing and reviewing standard processes and templates within Global Medical Writing
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned.
SCOPE This position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.
EDUCATION Bachelor's or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
EXPERIENCE Relevant Experience:
Up to 2 years as a medical writer in the pharmaceutical industry
At least 5 years of medical or scientific writing experience as a primary job responsibility
Clinical Studies Familiar with drug development process (discovery to market).
Basic understanding of biostatistical and clinical research concepts.
Basic applied knowledge of documentation required for the conduct of clinical studies:
protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)
study results reporting
Medical Writing Writing high-quality documents that support corporate goals and objectives.
Experience writing, reviewing, or editing protocols and clinical study reports preferred.
Basic applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.
Ability to interpret basic tabular and graphical clinical data presentations.
Ability to create basic tables using AMA style (eg, Schedule of Events).
Basic to intermediate applied knowledge of basic clinical laboratory tests.
Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
Computer/office equipment Skills Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, and PowerPoint.
Familiar with document management software (eg, LiveLink, SharePoint, Veeva)
Experienced with scanners, printers, and copiers.
Regulatory Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
Project Management Capable of working on multiple tasks and shifting priorities.
Good conflict management skills.
Motivated and shows initiative.
Detail oriented.
Communication 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.
Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
The salary range for this position is: $74,100 to $100,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://careers.biomarin.com/benefits.
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
#J-18808-Ljbffr
In Summary: The Medical Writer 1 applies basic to intermediate documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies . The position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals .
En Español: Who We Are BioMarin es una compañía global de biotecnología que persigue sin descanso la ciencia audaz para traducir los descubrimientos genéticos en nuevos medicamentos que promuevan el futuro de la salud humana. Desde nuestra fundación en 1997, hemos aplicado nuestra experiencia científica en comprender las causas subyacentes de las condiciones genéticas para crear medicamentos transformadores, utilizando varias modalidades de tratamiento. Utilizando nuestra incomparable experiencia en genética y biología molecular, desarrollamos medicamentos para pacientes con necesidades médicas significativas insatisfechas. Reclutamos a los mejores - personas con la experiencia técnica adecuada y un impulso implacable para resolver problemas reales - y creamos un entorno que empodere a nuestros equipos a perseguir ciencias científicas innovadoras. Con este enfoque distintivo al descubrimiento de fármacos, hemos producido una diversidad de grupos comerciales, clínicos y preclínicos candidatos que han soportado la biología e ofrecen una oportunidad de ser beneficiados por el mercado de investigación o desarrollo clínico asociado. Nuestros equipos trabajan para desarrollar terapias de primera clase y mejores en su categoría que proporcionen avances significativos a los pacientes que viven con enfermedades genéticas. El Medical Writer 1 aplica habilidades básicas de preparación de documentación intermedia y gestión del proyecto de documentos para ayudar al desarrollo, redacción, revisión, edición y finalización de documentos utilizados en la realización de estudios clínicos e informes sobre resultados de estudio clínico para presentaciones y publicaciones regulatorias. RESPONSIBILITIES Los proyectos y ediciones se utilizan para llevar a cabo e informar los resultados de estudios médicos, incluidos protocolos, enmiendas de protocolo, formularios de consentimiento informado e informes de estudio clinico Los proyectos de diseño y modificación de documentos usados para reportar información agregada de seguridad y eficacia para una molécula, como los grupos de investigación médica y las normas periódicas de seguridad durante el proceso de elaboración (PRERs, DSPEAs, AURnCOD etc.) Este departamento proporciona un análisis técnico y otros procedimientos de trabajo dentro de la organización y la administración de procesos de evaluación, así como otras tareas relacionadas con la implementación de planes de estudio y las prácticas de estudio, la elaboración de evaluaciones técnicas y la evaluación de datos y de piezas administrativas, además de organizar y gestionar todos los aspectos relacionados con los requisitos técnicos y funciones de la industria. El cumplimiento de esta necesidad con un empleado a tiempo completo regular permitirá que BioMarin reduzca los costos relacionados con la escritura y el encargo del contratista, aumente la productividad en Medicinal Writing para satisfacer las necesidades de desarrollo y realize eficiencias y una calidad de documentación consistente a través de programas mediante procesos repetibles y continuidad de conocimiento de programas, productos de investigación e indicaciones. Evidencia de desarrollo profesional de escritura médica deseable, por ejemplo, certificado básico de la Asociación Americana de Escritores Médicos y Medicamentos. Básico conocimiento básica aplicado de la documentación requerida para llevar a cabo estudios clínicos: diseño del protocolo (incluyendo objetivos, puntos finales de eficacia y seguridad, y procedimientos para recopilar e informar AEs y SAEs). Experiencia relevante: Hasta 2 años como escritor médico o científico en la industria farmacéutica Al menos 5 años de experiencia en redacción médica como una responsabilidad laboral principal Estudios clínicos Familiar con el proceso de desarrollo de fármacos (descubrimiento al mercado). Comprensión básica de los conceptos básicos de investigación clínica biostática y medicamento. Todos los solicitantes calificados recibirán consideración para el empleo sin importar la raza, color, religión, sexo, orientación sexual, identidad de género, origen nacional o estatus de veterano protegido y no serán discriminados en función de su discapacidad. El rango salarial para este puesto es: $74,100 a $100,000. BioMarin tiene en cuenta una variedad de factores al determinar la compensación básica, incluida experiencia, cualificaciones y ubicación geográfica. Estas consideraciones significan que la indemnización real varía.
About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
The Medical Writer 1 applies basic to intermediate 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 in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.)
Aids in managing 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
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Assists in developing and reviewing standard processes and templates within Global Medical Writing
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned.
SCOPE This position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.
EDUCATION Bachelor's or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
EXPERIENCE Relevant Experience:
Up to 2 years as a medical writer in the pharmaceutical industry
At least 5 years of medical or scientific writing experience as a primary job responsibility
Clinical Studies Familiar with drug development process (discovery to market).
Basic understanding of biostatistical and clinical research concepts.
Basic applied knowledge of documentation required for the conduct of clinical studies:
protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)
study results reporting
Medical Writing Writing high-quality documents that support corporate goals and objectives.
Experience writing, reviewing, or editing protocols and clinical study reports preferred.
Basic applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.
Ability to interpret basic tabular and graphical clinical data presentations.
Ability to create basic tables using AMA style (eg, Schedule of Events).
Basic to intermediate applied knowledge of basic clinical laboratory tests.
Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
Computer/office equipment Skills Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, and PowerPoint.
Familiar with document management software (eg, LiveLink, SharePoint, Veeva)
Experienced with scanners, printers, and copiers.
Regulatory Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
Project Management Capable of working on multiple tasks and shifting priorities.
Good conflict management skills.
Motivated and shows initiative.
Detail oriented.
Communication 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.
Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
The salary range for this position is: $74,100 to $100,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://careers.biomarin.com/benefits.
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
#J-18808-Ljbffr
In Summary: The Medical Writer 1 applies basic to intermediate documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies . The position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals .
En Español: Who We Are BioMarin es una compañía global de biotecnología que persigue sin descanso la ciencia audaz para traducir los descubrimientos genéticos en nuevos medicamentos que promuevan el futuro de la salud humana. Desde nuestra fundación en 1997, hemos aplicado nuestra experiencia científica en comprender las causas subyacentes de las condiciones genéticas para crear medicamentos transformadores, utilizando varias modalidades de tratamiento. Utilizando nuestra incomparable experiencia en genética y biología molecular, desarrollamos medicamentos para pacientes con necesidades médicas significativas insatisfechas. Reclutamos a los mejores - personas con la experiencia técnica adecuada y un impulso implacable para resolver problemas reales - y creamos un entorno que empodere a nuestros equipos a perseguir ciencias científicas innovadoras. Con este enfoque distintivo al descubrimiento de fármacos, hemos producido una diversidad de grupos comerciales, clínicos y preclínicos candidatos que han soportado la biología e ofrecen una oportunidad de ser beneficiados por el mercado de investigación o desarrollo clínico asociado. Nuestros equipos trabajan para desarrollar terapias de primera clase y mejores en su categoría que proporcionen avances significativos a los pacientes que viven con enfermedades genéticas. El Medical Writer 1 aplica habilidades básicas de preparación de documentación intermedia y gestión del proyecto de documentos para ayudar al desarrollo, redacción, revisión, edición y finalización de documentos utilizados en la realización de estudios clínicos e informes sobre resultados de estudio clínico para presentaciones y publicaciones regulatorias. RESPONSIBILITIES Los proyectos y ediciones se utilizan para llevar a cabo e informar los resultados de estudios médicos, incluidos protocolos, enmiendas de protocolo, formularios de consentimiento informado e informes de estudio clinico Los proyectos de diseño y modificación de documentos usados para reportar información agregada de seguridad y eficacia para una molécula, como los grupos de investigación médica y las normas periódicas de seguridad durante el proceso de elaboración (PRERs, DSPEAs, AURnCOD etc.) Este departamento proporciona un análisis técnico y otros procedimientos de trabajo dentro de la organización y la administración de procesos de evaluación, así como otras tareas relacionadas con la implementación de planes de estudio y las prácticas de estudio, la elaboración de evaluaciones técnicas y la evaluación de datos y de piezas administrativas, además de organizar y gestionar todos los aspectos relacionados con los requisitos técnicos y funciones de la industria. El cumplimiento de esta necesidad con un empleado a tiempo completo regular permitirá que BioMarin reduzca los costos relacionados con la escritura y el encargo del contratista, aumente la productividad en Medicinal Writing para satisfacer las necesidades de desarrollo y realize eficiencias y una calidad de documentación consistente a través de programas mediante procesos repetibles y continuidad de conocimiento de programas, productos de investigación e indicaciones. Evidencia de desarrollo profesional de escritura médica deseable, por ejemplo, certificado básico de la Asociación Americana de Escritores Médicos y Medicamentos. Básico conocimiento básica aplicado de la documentación requerida para llevar a cabo estudios clínicos: diseño del protocolo (incluyendo objetivos, puntos finales de eficacia y seguridad, y procedimientos para recopilar e informar AEs y SAEs). Experiencia relevante: Hasta 2 años como escritor médico o científico en la industria farmacéutica Al menos 5 años de experiencia en redacción médica como una responsabilidad laboral principal Estudios clínicos Familiar con el proceso de desarrollo de fármacos (descubrimiento al mercado). Comprensión básica de los conceptos básicos de investigación clínica biostática y medicamento. Todos los solicitantes calificados recibirán consideración para el empleo sin importar la raza, color, religión, sexo, orientación sexual, identidad de género, origen nacional o estatus de veterano protegido y no serán discriminados en función de su discapacidad. El rango salarial para este puesto es: $74,100 a $100,000. BioMarin tiene en cuenta una variedad de factores al determinar la compensación básica, incluida experiencia, cualificaciones y ubicación geográfica. Estas consideraciones significan que la indemnización real varía.