Senior Regulatory Medical Writer, sponsor-dedicated

2 weeks ago

Maidenhead Berkshire, United Kingdom Fortrea Full time

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

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