Medical Writer

hace 6 meses

Madrid, España PSI CRO A tiempo completo

Company Description

PSI is a leading Contract Research Organization with more than 28 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

**Job Description**:

- Writes, edits, and reviews Essential Documents, including protocols, clinical study reports (CSRs), CSR safety narratives, informed consent forms, patient information, regulatory submission documents (e.g., sections for INDs/NDAs/BLAs), and other project-specific clinical documentation
- Ensures quality and compliance of PSI-developed Essential Documents with applicable QSDs, pertinent regulatory requirements, and client specifications
- Critically assesses, interprets, and summarizes data from clinical studies
- Reviews scientific literature and client source documents pertinent to medical writing activities
- Develops and maintains templates for study-specific documents and guidelines, conforming to client and regulatory requirements (as assigned by the Director or Associate Director, Medical Writing)
- Acts as a primary or secondary contact for the client and/or the sponsor (if not the same entity), and other PSI functional areas within the scope of assigned medical writing tasks

**Qualifications**:

- College or university degree, preferably a Bachelor’s/Master’s degree in biomedical or life science fields, or a PhD degree in medical/ journalism fields, or a relevant combination of education, training, and experience that presents the required knowledge, skills, and abilities.
- Minimum 2 years of corresponding industry experience working with clinical documentation and data
- Prior pharmaceutical, biotechnology, or contract research organization experience
- Excellent knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential Documents
- Industry experience in preparation of ICH E3 compliant Clinical Study Reports (CSRs) and related documents

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

  • Principal Medical Writer

    hace 6 meses

    Madrid, España Sobi A tiempo completo

    **Company Description** Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. We...

  • Medical Writer

    hace 6 meses

    Madrid, España Page Personnel España A tiempo completo

    Formarás parte de importante agencia de referencia ubicada en Madrid, siendo tus responsabilidades: - ** Responsable de la creación de propuestas y contenidos para las cuentas asignadas.**: - **Propuesta y seguimiento de contenidos y aproximaciones médico / científicas rigurosas y de calidad para las cuentas asignadas.**: - **Trabajar en estrecha...

  • Senior Medical Writer

    hace 1 mes

    Madrid, España Tfs Healthscience A tiempo completo

    About this role TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.The Senior Medical Writer is part of the...

  • Senior Medical Writer

    hace 1 mes

    Madrid, España Tfs Healthscience A tiempo completo

    About this roleTFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.The Senior Medical Writer is part of the...

  • Senior Medical Writer

    hace 1 mes

    Madrid, España TFS HealthScience A tiempo completo

    About this roleTFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.The Senior Medical Writer is part of the...

  • Senior Medical Writer

    hace 1 mes

    Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    Role SummaryAs a Senior Medical Writer at Syneos Health, you will play a pivotal role in developing high-quality clinical content for our clients. You will work closely with cross-functional teams to create compelling narratives that drive project success. This is an excellent opportunity to leverage your writing expertise and passion for healthcare to make...

  • Scientific Communication Lead/ Medical Writer

    hace 6 meses

    Madrid, España MphaR A tiempo completo

    **About MphaR**: MphaR is a company providing services in the area of Medical Affairs. We assist clients who develop innovative therapies. MphaR supports companies in pre-launch and launch/post-launch phases. MphaR’s competitive advantage is in its focus, dedication and flexibility. MphaR is focused on providing a full range of services in the area of...

  • Scientific Communication Lead/ Medical Writer

    hace 6 meses

    Madrid, España MphaR A tiempo completo

    **About MphaR**: MphaR is a company providing services in the area of Medical Affairs. We assist clients who develop innovative therapies. MphaR supports companies in pre-launch and launch/post-launch phases. MphaR’s competitive advantage is in its focus, dedication and flexibility. MphaR is focused on providing a full range of services in the area of...

  • Medical Writer Specialist

    hace 1 semana

    Madrid, Madrid, España Syneos Health A tiempo completo

    Job SummaryWe are seeking a Medical Writer Specialist to join our Clinical Development team at Syneos Health. As a key member of our team, you will be responsible for mentoring and leading less experienced medical writers on complex projects, representing the Medical Writing department on clinical study teams, and advising clients and study teams on data...

  • Senior Medical Writer Lead

    hace 3 semanas

    Madrid, Madrid, España Syneos Health A tiempo completo

    **Job Overview**Syneos Health, a leading biopharmaceutical solutions organization, is seeking an experienced Senior Medical Writer Lead to accelerate customer success. As a key member of our Clinical Development team, you will work collaboratively with passionate problem solvers to innovate and deliver high-quality writing services.**Estimated Salary:...

  • Senior Medical Writer

    hace 1 mes

    Madrid, España TFS HealthScience A tiempo completo

    **About this role** TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions. Senior Medical Writer is part of the...

  • Senior Medical Writer

    hace 4 semanas

    Madrid, España Tfs Healthscience A tiempo completo

    TFS Health Science is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.Join Our Team as a (job title) About this role As part of...

  • Senior Medical Writer

    hace 1 mes

    Madrid, España Tfs Healthscience A tiempo completo

    About this role  TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.Senior Medical Writer is part of the...

  • Senior Medical Writer

    hace 4 semanas

    Madrid, España Tfs Healthscience A tiempo completo

    About this role TFS Health Science is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.Senior Medical Writer is part of the...

  • Medical Writer and Editor

    hace 15 horas

    Madrid, Madrid, España Syneos Health, Inc. A tiempo completo

    About the Position:We are seeking an experienced Medical Writer and Editor to join our team. As a Medical Writer and Editor, you will be responsible for creating high-quality clinical documents, editing and revising written content, and ensuring compliance with regulatory requirements.About Us:Syneos Health, Inc. is a leading integrated biopharmaceutical...

  • Lead Medical Writer

    hace 4 semanas

    Madrid, Madrid, España Syneos Health, Inc. A tiempo completo

    As a key member of the Syneos Health team, you will have the opportunity to work on high-profile clinical study projects and develop your skills as a medical writer. With a strong focus on mentoring and leadership, this role is perfect for those looking to take their writing career to the next level.We are committed to fostering a culture of diversity,...

  • Senior Medical Writer

    hace 4 semanas

    Madrid, España TFS HealthScience A tiempo completo

    About this role TFSHealthScience is a leading global, mid-size Contract Research Organization(CRO) that partners with biotechnology and pharmaceutical companies throughouttheir entire clinical development journey. Our expertise includes fullservice-capabilities, resourcing and functional service (FSP) solutions.Senior Medical Writer is part of the Medical...

  • Senior Medical Writer

    hace 5 días

    Madrid, España TFS HealthScience A tiempo completo

    About this role TFSHealthScience is a leading global, mid-size Contract Research Organization(CRO) that partners with biotechnology and pharmaceutical companies throughouttheir entire clinical development journey. Our expertise includes fullservice-capabilities, resourcing and functional service (FSP) solutions.Senior Medical Writer is part of the Medical...

  • Sr / Regulatory Medical Writer - Certain Emea

    hace 6 meses

    Madrid, España Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Sr / Regulatory Medical Writer - Certain Emea

    hace 7 meses

    Madrid, España Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...