Senior Regulatory Medical Writer, sponsor-dedicated

hace 4 semanas


Alcobendas, España Fortrea A tiempo completo

As 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 conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

WHAT YOU WILL DO

Imbedded in the team of one of the world´s leading pharma companies, you will be one of the primary , project leading the Development Cycle for high-complexity Phase II-IV clinical regulatory documents.

We´ll trust you to spearhead the entire process, from initial planning and coordination through all stages of development, culminating in the final delivery to the sponsor.

From the variety of documents you will work on (Investigator´s Brochures, Safety Narratives, ICFs, Efficacy Summaries, Regulatory responses, etc.,) your contribution will be essential developing:

Protocols and Clinical Study Reports (CSRs)

With minimal supervision, during Planning stage , you will:

Lead Kick-off strategy meetings, to align geographically distributed teams, setting goals, milestones, and critical path forward. Conduct Communication strategy meetings, to consolidate contributions from experts to produce a cohesive Shell Skeleton Report. Facilitate Comment resolution meetings, to manage conflicting comments early and ensuring smooth protocol development.

During document development , you will:

Maintain alignment with sponsor goals, project status and milestones across all teams. Foster regular communication with functional leads/reviewers to streamline document development (getting inputs timely, consolidating contributions, answering questions.)

Once final data is received:

Critically interpret raw study data (efficacy, exposure, end-point, safety, etc.) into clear concise language in Protocols and CSRs.

WHO YOU WILL WORK WITH

You will coordinate functional leads and reviewers from the Biostatistics, Data Management, Programming, Clinical Leadership and Project Physician teams. Additionally, you will engage with Medical Writing teams across Europe, and also the Americas and Asia-Pacific.

LOCATIONS

This is a full-time , permanent job.

Our ideal locations are: UK, Spain, Germany and France .

YOUR EXPERIENCE

Advanced degree in life-sciences (PhD or Masters) Minimum 4 years of regulatory medical writing experience, including at least 2 years as medical writing project lead . Extensive experience and proficiency in writing and leading development of CSRs and Protocols .

PERSONAL/TEAM SKILLS

You´ll be the nexus where multiple teams´ expertise converge:

You will leverage your experience to manage writing projects, coordinate and collaborate with stakeholders, steer discussion, drive consensus and facilitate decision-making to propel the document development cycle forward. 

To drive development of documents of this scale forward, this role requires visibility, proactivity, collaboration/teamwork, and excellent communication skills.

You must be comfortable leading team discussions, managing complex medical writing tasks and processes, engaging with a variety of stakeholders, and confidently contributing your expertise based on experience.

Integration within the client´s team is crucia l:

Are you prepared to assume augmented responsibilities and adaptability across environments and therapeutic areas?

A UNIQUELY DIVERSE CAREER

At Fortrea, we empower you to shape your own career path.

Whether you are passionate about the medical writing scientific side, or aspire to leadership roles, we provide comprehensive training, management support, a network of SME’s and KOL’s and opportunities to help you thrive.

Your aspirations drive your journey with us. Where do you see yourself?

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.



  • Alcobendas, España Fortrea A tiempo completo

    As 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 Medical Writer

    hace 3 semanas


    Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.   Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our...

  • Regulatory Manager

    hace 4 semanas


    Alcobendas, España Precision Medicine Group A tiempo completo

    Precision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland.Position Summary:The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings,...


  • Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.   Are you a talented Regulatory Affairs professional with experience in project management, Veeva Vault, MAA, and WHO exposure? We are currently seeking a Regulatory Affairs Associate or Senior Associate to join our dynamic team. In this client-dedicated role, you will be responsible for...


  • Alcobendas, España Fortrea A tiempo completo

    As 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...


  • Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.   Parexel is seeking highly motivated and experienced individuals for the position a Senior Regulatory Affairs Associate. This role can be home, or office based in various locations in Europe. As part of our team, you will have the opportunity to work within a collaborative environment and...


  • Alcobendas, España Fortrea A tiempo completo

    As 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...


  • Poligono Industrial Alcobendas, España Stryker Corporation A tiempo completo

    **What we are looking for**: **Talent developers. **Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members. **Network builders. **Managers who build connections with other teams and divisions and coordinate cross-functional collaboration. **Compliance-focused orchestrators.** Managers who...

  • Senior Technical Writer

    hace 1 semana


    Alcobendas, España Grafana Labs A tiempo completo

    This is a remote position for EMEADescription of DutiesWe are looking for a Technical Writer to produce high-quality documentation and guides for Grafana Labs. You will collaborate with the engineers, developer advocates, support engineers, product managers, and the Grafana technical writing team to produce a variety of tailored content to ensure our...


  • Alcobendas, España Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Clinical Trial Manager

    hace 3 semanas


    Alcobendas, España Precision Medicine Group A tiempo completo

    We have current opportunity for an experienced Clinical Trial Manager in Europe! Join our growing team.Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data...


  • Alcobendas, Madrid, España Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Alcobendas, España Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • student

    hace 1 día


    Alcobendas, Madrid, España Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • student

    hace 1 día


    Alcobendas, España Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Alcobendas, España Precision Medicine Group A tiempo completo

    Precision for Medicine is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.We are currently hiring...


  • Alcobendas, España Fortrea A tiempo completo

    As 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...


  • Alcobendas, España Vonage A tiempo completo

    Vonage Engineering Mission: Vonage is the emerging leader in the $100B+ cloud communications platform (CPaaS) market. Customers like Airbnb, Viber, Whatsapp, Snapchat, and many others depend on our APIs and SDKs to connect with their customers all over the world. As businesses continue to shift to a real-time, customer-centric communications model, we...


  • Alcobendas, España Stryker A tiempo completo

    **Why join Stryker?**: Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific. **Know someone at Stryker?**: We are looking for commercially savvy...

  • Quality Complaint Analyst

    hace 3 semanas


    Alcobendas, España Institut Straumann Ag A tiempo completo

    About Straumann Group Headquartered in Basel, Switzerland, the Straumann Group stands at the pinnacle of dental innovation, with a reach spanning more than 100 countries worldwide. We pride ourselves on our expansive network of distribution subsidiaries and partners, showcasing global brands such as Straumann, Neodent, Medentika, DR SMILE, TeethToday, and...