Sponsor Dedicated Clinical Editor/senior
hace 2 semanas
**Description**
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**
**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
**Job responsibilities**
This position is responsible for quality control (QC) review of clinical documents intended for submission to health authorities worldwide. The Senior Clinical Editor will copyedit/proofread, format, and verify data content in clinical documents in accordance with company SOPs and processes to ensure documents meet required standards, and may oversee the workload for the editors, establishing schedules and interacting with cross-functional authors. The Clinical Editor performs the activities with mínimal oversight needed.
- Perform QC review of documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents) to ensure compliance with the Style Guide and submission standards.
- Verify data in documents against the source tables, figures, and listings and format tables according to company standards.
- Copyedit/proofread clinical documents for grammar, style, and formatting according to company style guides.
- Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect source documents or data (eg, SAS tables and listings).
- Check reference list in documents, including verifying citation information vs PubMed, ordering copies of references and adding to the electronic document management system (EDMS), and ensuring each reference is cross-referenced in the document.
- Proofread documents against the standard templates to ensure compliance with required sections and text.
- Perform publishing of nonclinical and clinical documents and the compilation of required CSR appendices, as needed.
- Lead and actively participate in process improvement initiatives and assist Medical Writing staff with other tasks, as appropriate.
- May oversee the workload for the editors, establishing schedules and interacting with cross-functional authors.
- Assist with training of more junior editors or contract staff.
LI-NC1
**Qualifications**
**What we’re looking for**
- Bachelor’s degree in English, Basic Science, Business, or other analytical field with related experience in the pharmaceutical industry in a discipline directly related to document production (eg, medical writing, QC, editing, publishing).
- Strong working knowledge of the editorial and publishing activities within Clinical Development.
- Strong working knowledge of Adobe PDF bookmarking and internal/external hyperlinking to meet submission-ready standards.
- Experience in the use of an EDMS (eg, Veeva Vault or SharePoint).
- Ability to effectively communicate with vendors and manage outsourced editorial work.
- Keen attention to detail.
**Get to know Syneos Health**
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
**Additional Information**:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivale
-
Sponsor Dedicated Clinical Operations Manager
hace 7 días
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Description - External** **Sponsor Dedicated Clinical Operations Manager - Barcelona Home Based** **Required: previous experience as Line Manager** **Experience in Sponsor dedicated model would be considered a plus** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer...
-
Senior Clinical Research Associate
hace 2 semanas
Barcelona, España Sdi Digital Group A tiempo completoSenior Clinical Research Associate IQVIA is the Human Data Science Company oriented to drive human health outcomes forward. When you join IQVIA Spain as a sponsor-dedicated CRA, you'll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to world-class...
-
Sr Clinical Trial Manager
hace 7 días
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Senior Clinical Trial Manager** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...
-
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Sponsor Dedicated Global Clinical Project Manager - Home Based in Spain** Previous experience in global trial management and vendors management is required. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and...
-
Senior Clinical Research Associate
Encontrado en: Talent ES C2 - hace 1 semana
Barcelona, España IQVIA A tiempo completoSenior Clinical Research Associate IQVIA is the Human Data Science Company oriented to drive human health outcomes forward. When you join IQVIA Spain as a sponsor-dedicated CRA, you’ll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to...
-
Experienced Cra Ii
hace 7 días
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **CRA II / Senior Clinical Research Associate I/II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide...
-
Sr Project Manager. Spain. Sponsor Dedicated
hace 4 días
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Senior Project Manager** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...
-
Medical Writer I in Barcelona. Sponsor Dedicated
hace 6 días
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Medical Writer I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...
-
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Medical Writer II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...
-
Cra-single Sponsor-promocion a Senior en 1 Año
hace 7 días
Barcelona, España NonStop Consulting A tiempo completoTengo un puesto de CRA en el que de media en 1 año te promocionan a Senior, es un puesto homebased para una CRO internacional. El puesto es sponsor dedicated por lo que no hay un numero minimo de visitas de monitorizacion y algunas de las visitas son remotas. **Responsabilidades**: Realizar visitas Administrar el protocolo y la capacitación de...
-
Clinical Trial Manager, Investigator Sponsored
hace 6 días
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Clinical Trial Manager, Investigator Sponsored Studies - Home Based in Italy or Spain** The role is Sponsor dedicated. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address...
-
Cra Ii y Senior Cra-single Sponsor-escoge El Área
hace 6 horas
Barcelona, España NonStop Consulting A tiempo completoTengo varios puestos como CRA II y Senior CRA en los que puedes elegir el área terapéutica en la que trabajas. Est se debe a que nuestro cliente tiene varios sponsors y tendrán en cuenta tus preferencias, este es un puesto sponsor dedicated con sede en Barcelona ya que los sponsors están ubicados en Barcelona. **Responsabilidades**: Realizar...
-
Manager Clinical Operations
Encontrado en: beBee S ES - hace 4 semanas
Barcelona, España ICON Clinical Research A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Senior Clinical Program Director, Early Clinical
hace 6 horas
Barcelona, España AstraZeneca A tiempo completoThe Senior Clinical Program Director (Senior CPD) is accountable for the overall delivery of the clinical program to time, cost and quality and is the leader of the Clinical Program Team (CPT). The Senior CPD will be required to work closely with the core CPT members to ensure that the clinical strategy and deliverables for the clinical program are delivered...
-
Senior Clinical Research Associate
Encontrado en: Talent ES C2 - hace 1 semana
Barcelona, España Worldwide Clinical Trials A tiempo completoRequisition Number7739Employment Type:Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...
-
Senior Clinical Data Manager
Encontrado en: Talent ES C2 - hace 1 semana
Barcelona, España Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Senior Cra I Jobs
hace 4 días
Barcelona, España NonStop Consulting A tiempo completoUna CRO internacional ql busca a Senior CRA I (CRAs con minimo 3 años de experiência como CRA) en cualquier area terapeutica, no hace falta tener experiência en oncologia. Las vacantes son indefinidas y homebased en el area de Barcelona aunque hay opcion de ir a la oficina si lo deseas y son para trabajar para un solo sponsor, ofrecen ademas horario...
-
Barcelona, España AstraZeneca A tiempo completo**Senior Global Clinical Operations Program Director** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Join a...
-
Senior Clinical Program Director
hace 6 horas
Barcelona, España Morgan Philips Executive Search A tiempo completoImportant pharmaceutical company is looking for a Senior Clinical Program Director who will be accountable for the overall delivery of the clinical program to time, cost and quality and is the leader of the Clinical Program Team. Typical Accountabilities Accountable for leading the translation of science into crisp and robust clinical development plans,...
-
Editor/a Senior
Encontrado en: beBee S ES - hace 3 semanas
Barcelona, España Grupo Planeta A tiempo completoDesde la división Editorial de Grupo Planeta, en concreto para nuestro sello Ariel, incorporamos un/a Editor/a Senior.Buscamos un perfil que entienda la creatividad como resultado de la combinación entre versatilidad y entusiasmo. Necesitamos muchas ideas, y todavía más ganas de convertirlas en realidad. ¿Qué hacemos en Ariel?Ariel, editorial...