Quality Control Specialist, Medical Writing Job at BeiGene in New York

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The QC Specialist is responsible for coordinating and completing assigned QC reviews, ensuring that clinical and regulatory documents undergo review, copyediting, data verification, and proofreading in a manner that conforms to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical and regulatory documents include study reports, clinical study protocols or amendments, investigator's brochures, and the clinical sections of INDs, NDAs, MAAs, and other regulatory submission documents. Other documents may include manuscripts, abstracts, posters, briefing documents, responses to health authorities, narratives, and any other documents authored or supported by Global Medical Writing that require a QC review.

This work can be done remotely or from any of BeOne's global offices.

Essential Functions of the Job:

Document Review and Editing :

Works effectively within the Global Medical Writing department to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents.
Responsible for performing a quality check of clinical and regulatory documents before approval. Performs cross-referencing, fact-checking, and general quality assessments of documents.
Proofreads documents for grammatical and formatting errors, hyperlink functionality, data source verification, and proper translation of data.
Ensures compliance with Global Medical Writing conventions, processes, templates and applicable regulatory guidelines.

Maintains strong attention to detail (ie, to consistency, grammar, syntax, and scientific accuracy) while performing technical edits.
Project and Process Management: Ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality QC reviews according to tight timelines and shifting priorities/demands.
Adheres to QC timelines and communicates with Medical Writers to maintain awareness of expectations, milestones, and deliverables.
Contributes to team direction and strategy discussions, with guidance from managers and mentors.
Influence and Training: Builds effective partnerships with all intradepartmental teams when collaborating on QC reviews and projects.
Engages in trainings that will increase knowledge of medical writing, the types of documents in the scope of the Global Medical Writing team, medical terminology, and the development of drugs and biologics.
Qualifications: Demonstrated ability to communicate in clear, concise, and effective English (both written and verbal).
Experience in conducting medical writing QC reviews of pharmaceutical industry regulatory documents (such as clinical study reports, protocols, and protocol amendments) or experience in technical editing in a related or similar industry; experience in reviewing clinical sections of INDs, MAAs, and NDAs is a plus.
Familiarity with the general process of drug/biologics development as well as the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines is preferred.
Supervisory Responsibilities:

Not applicable for this role.

Other Qualifications: Effective Communication: Explains own work clearly. Able to escalate questions/issues to appropriate stakeholders at an early stage, with guidance from manager/mentor. Takes part in discussions with different viewpoints, and be able to provide value-added inputs with guidance from manager/mentor.
Embracing Change: Always seeking and open to new opportunities and changes. Copes well with change and new challenges with guidance from manager/mentor. Contributes to specific change activities.
Creating Innovation: Demonstrates openness to innovation and applies new ways of working (eg, skills or techniques) in own work to improve time management, timeliness, and accuracy.
Thinking Strategically: Understands key concepts (eg, strategic review, lean writing) related to own work with guidance from manager/mentor. Demonstrates awareness of company strategies and general events happening in the industry (eg, regulations, guidelines, and trends).
Mentoring: Provides specific feedback to others within own team as requested. Solicits feedback and accepts and integrates changes from constructive criticism. Willingly shares own knowledge and experience to support others' learning.
Computer Skills : Technical expertise in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat.
Proficiency in navigating Microsoft Windows.
Familiarity with SharePoint and Veeva Vault is a plus.
Travel:

Not applicable.

Education Required:

BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus.

At least 1 year of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity

Salary Range: $74,600.00 - $99,600.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

In Summary: QC Specialist is responsible for coordinating and completing assigned QC reviews of clinical and regulatory documents . This work can be done remotely or from any of BeOne's global offices . BeOne values our values of Patient First, Driving Excellence, Bold Ingenuity and Collaborative Collaboration through our twelve global competencies .

En Español: BeOne continúa creciendo a un ritmo rápido con oportunidades desafiantes y emocionantes para profesionales experimentados. Al considerar candidatos, buscamos profesionales científicos y empresariales que estén altamente motivados, colaborativos y, lo más importante, compartan nuestro apasionado interés en la lucha contra el cáncer. Descripción general: El especialista QC es responsable de coordinar y completar las revisiones asignadas de QC, asegurándose de que los documentos clínicos y regulatorios se sometan a revisión, edición copiada, verificación de datos y corrección de una manera que cumpla con la presentación regulatoria nacional e/o internacional y estándares internos del documento, mientras cumplen con los plazos del proyecto. Otros documentos pueden incluir manuscritos, resúmenes, carteles, documentos de información, respuestas a las autoridades sanitarias, narraciones y cualquier otro documento escrito o apoyado por Global Medical Writing que requiera una revisión QC. Este trabajo puede realizarse remotamente o desde cualquiera de los oficinas globales de BeOne. Funciones esenciales del Trabajo: Revisión y edición de documentos:. Realiza referencias cruzadas, comprobación de hechos y evaluaciones generales de la calidad de los documentos. Proyecto y gestión de procesos: Capacidad para priorizar tareas, trabajar simultáneamente en múltiples proyectos, y completar revisiones QC de alta calidad según plazos médicos ajustados y prioridades/demandas cambiantes. Asegura el cumplimiento de las convenciones, procesos, plantillas y directrices regulatorias aplicables a la redacción médica global. Mantiene una fuerte atención al detalle (es decir, a la consistencia, gramática, sintaxis y precisión científica) mientras realiza modificaciones técnicas. Gestión del proyecto y proceso: Habilidad para priorizar tareas; trabajo simultáneo en varios proyectos, funcionalidad de hipervínculos, verificación de fuentes de datos y traducción adecuada de datos. Se adhiere a cronogramas clínicos y se comunica con los escritores médicos para mantenerse consciente de las recomendaciones, milestones mentales y consejos administrativos. Capacidad para escalar preguntas/cuestiones a las partes interesadas apropiadas en una etapa temprana, con orientación del gerente / mentor. Participa en discusiones con diferentes puntos de vista y puede proporcionar aportes de valor añadido con la guía del gerentes / mentores. Adoptar el cambio: Siempre buscando y abierto a nuevas oportunidades y cambios. Aborda bien los cambios y nuevos desafíos con la dirección del manager / mentor . Contribuye al cambio de actividades específicas. Crear innovación: demuestra apertura a la innovación y aplica nuevas formas de trabajar (por ejemplo, habilidades o técnicas) en su propio trabajo para mejorar la gestión del tiempo, puntualidad y precisión. Pensamiento estratégico: entiende conceptos clave (p.ej., revisión estratégica, escritura suave) relacionados con el trabajo propio con la orientación de un gerente/mentor. Demuestra conciencia sobre las estrategias y eventos generales de la empresa dentro del sector (trends que suceden, acepta comentarios y reglamentaciones). Compartir voluntariamente su propio conocimiento y experiencia para apoyar el aprendizaje de los demás. Habilidades informáticas: Experiencia técnica en Microsoft Word, Microsoft Outlook, Excel, PowerPoint y Adobe Acrobat. Proficiencia en navegar por Microsoft Windows. Familiarización con SharePoint y Veeva Vault es una ventaja. Viajes: No aplicable. Educación Requerida: Grado BA/BS; Máster, PhD/PharmD u otro grado de posgrado es una plus. Al menos 1 año de experiencia relevante en la industria como editor QC / especialista, escritor médico o copywriter técnico anualmente. Competencias globales Cuando exhibimos nuestros valores de pacientes primero, excelencia en conducción, ingenio audaz e espíritu colaborativo, a través de nuestras doce competencias mundiales a continuación, ayudamos a obtener un salario más asequible para pacientes alrededor del mundo. El reclutador puede compartir más información sobre el rango salarial específico para una ubicación preferida durante el proceso de contratación. Tenga en cuenta que la gama enumerada refleja solo el salario base o el intervalo por hora. Los roles no comerciales son elegibles para participar en el plan de bonificación anual, y los roles comerciales pueden participar en un plan de compensación de incentivos. Todos los empleados de la Compañía tienen la oportunidad de poseer acciones de BeOne Medicines Ltd. porque todos los trabajadores son elegíveis para premios de equidad discrecionales y participar voluntariamente en el Plan de compra de acciones del Empleado. La compañía tiene un paquete completo de beneficios que incluye Medico, Dental, Visión, 401k), FSA / HSA, Seguro de vida, Merecimiento de tiempo pagado y Bienestar. Estamos orgullosos de ser un proveedor de igualdad de oportunidades.