Senior Regulatory Medical Writer, sponsor-dedicated

1 month ago


United Kingdom Fortrea Inc. Full time

Senior Regulatory Medical Writer, sponsor-dedicated page is loaded Senior Regulatory Medical Writer, sponsor-dedicated Apply locations Maidenhead United Kingdom Remote_Spain Remote_Germany Remote_France time type Full time posted on Posted 25 Days Ago job requisition id 2415765

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 Regulatory Medical Writers , 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. For more information about Fortrea, visit

Fortrea is proud to be an Equal Opportunity Employer:


As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement . 

#J-18808-Ljbffr
  • Senior Medical Writer

    1 month ago


    United Kingdom Fortrea Inc. Full time

    Senior Regulatory Medical Writer, sponsor-dedicated page is loaded Senior Regulatory Medical Writer, sponsor-dedicated Apply locations Maidenhead United Kingdom Remote_Spain Remote_Germany Remote_France time type Full time posted on Posted 25 Days Ago job requisition id 2415765 As a leading global contract research organization (CRO) with a passion for...


  • United Kingdom Carrot Pharma Recruitment Full time

    Senior Medical Writer - Regulatory/Clinical - Global CRO - Home based - £negotiable Senior Medical Writer - Regulatory/Clinical, responsible for researching, creating and editing all documents associated with clinical research. My client is a CRO covering multiple therapy areas. Based in the South East, this company have an exciting and broad variety of...

  • Senior Medical Writer

    3 weeks ago


    United Kingdom in Newbury Full time

    Role: Senior Medical Writer Working model: Can be based in London, Oxford I'm looking for an experienced Senior Medical Writer to join an established Healthcare Consultancy and support value communication materials such as global value dossiers, value stories, payer-facing materials, and HTA submission dossiers to reimbursement agencies around the...

  • Senior Medical Writer

    2 months ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and communicating complex scientific messages? Want to take the next step in your career and be part of a dynamic and supportive environment where your contributions make a difference? This Senior Medical Writer role with a focus on oncology publications...

  • Senior Medical Writer

    2 months ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and communicating complex scientific messages? Want to take the next step in your career and be part of a dynamic and supportive environment where your contributions make a difference?This Senior Medical Writer role with a focus on oncology publications...

  • Senior Medical Writer

    2 months ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and communicating complex scientific messages? Want to take the next step in your career and be part of a dynamic and supportive environment where your contributions make a difference? This Senior Medical Writer role with a focus on oncology publications...

  • Senior Medical Writer

    2 months ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and communicating complex scientific messages? Want to take the next step in your career and be part of a dynamic and supportive environment where your contributions make a difference?This Senior Medical Writer role with a focus on oncology publications...

  • Senior Medical Writer

    2 months ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and communicating complex scientific messages? Want to take the next step in your career and be part of a dynamic and supportive environment where your contributions make a difference? This Senior Medical Writer role with a focus on oncology publications...

  • Senior Medical Writer

    2 weeks ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and communicating complex scientific messages? Want to take the next step in your career and be part of a dynamic and supportive environment where your contributions make a difference? This Senior Medical Writer role with a focus on oncology publications...

  • Senior Medical Writer

    2 weeks ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and communicating complex scientific messages? Want to take the next step in your career and be part of a dynamic and supportive environment where your contributions make a difference? This Senior Medical Writer role with a focus on oncology publications...

  • Senior Medical Writer

    2 weeks ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and communicating complex scientific messages? Want to take the next step in your career and be part of a dynamic and supportive environment where your contributions make a difference?This Senior Medical Writer role with a focus on oncology publications...

  • Senior Medical Writer

    2 weeks ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and communicating complex scientific messages? Want to take the next step in your career and be part of a dynamic and supportive environment where your contributions make a difference? This Senior Medical Writer role with a focus on oncology publications...

  • Senior Medical Writer

    2 weeks ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and communicating complex scientific messages? Want to take the next step in your career and be part of a dynamic and supportive environment where your contributions make a difference?This Senior Medical Writer role with a focus on oncology publications...

  • Senior Medical Writer

    2 months ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and team leadership? This Principal Medical Writer role with a focus on oncology publications could just be what you are looking for. Apply today and we can book in a confidential chat to tell you more. You will need to be based in the UK and have at...

  • Senior Medical Writer

    2 months ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and team leadership? This Principal Medical Writer role with a focus on oncology publications could just be what you are looking for. Apply today and we can book in a confidential chat to tell you more. You will need to be based in the UK and have at...

  • Senior Medical Writer

    2 weeks ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and team leadership? This Principal Medical Writer role with a focus on oncology publications could just be what you are looking for. Apply today and we can book in a confidential chat to tell you more. You will need to be based in the UK and have at...

  • Senior Medical Writer

    2 weeks ago


    United Kingdom Medical Talent Full time

    Are you a seasoned Senior Medical Writer with a passion for scientific publications, client interaction, and team leadership? This Principal Medical Writer role with a focus on oncology publications could just be what you are looking for. Apply today and we can book in a confidential chat to tell you more. You will need to be based in the UK and have at...


  • United Kingdom Meet Full time

    Senior/ Principal Regulatory Writer - Clinical Trial Documentation/Submissions - Global Med Comms/Regulatory Agency - Remote - UK Thrilled to be partnering our client, a Global Medical Communications agency, to support them in their search for a Senior and Principal Regulatory Writer, to join their growing team in the UK. We are looking for an...


  • United Kingdom Meet Full time

    Senior/ Principal Regulatory Writer - Clinical Trial Documentation/Submissions - Global Med Comms/Regulatory Agency - Remote - UK Thrilled to be partnering our client, a Global Medical Communications agency, to support them in their search for a Senior and Principal Regulatory Writer, to join their growing team in the UK. We are looking for an...

  • Medical Writer

    2 months ago


    United Kingdom invoX Pharma Limited Full time

    Medical Writer - Contractor Department: Clinical Development Employment Type: Contract / Temp Location: invoX Remote (Rest of world) invoX is a research-driven global biopharmaceutical company using next-generation technology platforms to discover and develop innovative medicines that can change the lives of people around the world. Our vision is...