Medical Writer
1 month ago
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. We are seeking an experienced Medical Writer to lead authoring and development of high complexity clinical regulatory documents that are critical to the project(s) and strategic goals of our partner.
This is a full-time, remote job, EMEA.
You will serve as an expert contributor on our partner’s project teams. You will use your expertise and experience to write, advise, and coordinate development of complex clinical regulatory documents including Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, and clinical summary and overview documents in CTD/eCTD format for regulatory submissions world-wide.
This job is tailor-made for Medical Writers passionate about leading development of key documents that inform and align with project strategy.
Project Manager .
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.
Advanced degree (PhD or Masters)
Minimum 6 years medical writing experience, including 3 years as medical writing project lead .
Experience and proficiency in writing and leading development of a variety of clinical regulatory medical writing deliverables, including extensive experience leading content development of clinical summaries for eCTDs and drug applications across different regions.
Proven experience leading stakeholders/project teams through submission document development .
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.
If you thrive in medical writing and want to remain deeply involved in science with high-profile clients, Fortrea is your destination.
~ If you are coming to a point where you want to try management, we offer comprehensive training and support to prepare you for leadership roles.
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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Maidenhead, Berkshire, United Kingdom Fortrea Full timeAs 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...
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Maidenhead, United Kingdom Fortrea Full timeAs 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...
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