Senior Medical Writer

3 weeks 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. 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.,) With minimal supervision, during Planning stage , you will:
~ Maintain alignment with sponsor goals, project status and milestones across all teams.

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

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.
This is a full-time , permanent job.
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 .

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. 

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.

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.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. 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. For more information about how we collect and store your personal data, please see our Privacy Statement . 
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