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. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. We are on a mission to deliver solutions that bring life-changing treatments to patients faster. But we can´t do it alone. We are seeking an experienced Principal Medical Writer to lead authoring and development of high complexity clinical regulatory documents that are critical to the strategic projects of our partner. This is why we need you. Join Fortrea. Your job matters. This is a full-time, remote-based position in the US or Canada. WHAT YOU WILL DO You will work for one sponsor, imbedded on their team. Under this framework, you will act as an: Expert Contributor: You will serve as an expert contributor on our partner's project teams. You will use your expertise to write, advise, and coordinate development of complex clinical regulatory documents including Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, clinical summary modules and overview documents in CTD/eCTD format for regulatory submissions world-wide. Strategist: This job is tailor-made for Medical Writers who are passionate about leading the development of critical documents that shape and align with project strategy. You will play a pivotal role in ensuring that all written materials support the overall strategic goals of the project, making a lasting impact on its success. Project Manager: You will serve as a key liaison, bringing together the expertise of various teams. Leveraging your extensive experience, you will manage writing projects, collaborate with stakeholders, lead discussions, and drive consensus. Your role will be essential in facilitating decision-making and advancing the document development process efficiently. This position is ideal for someone who excels in cross-functional collaboration, project management, and producing high-quality medical writing deliverables. YOU NEED TO BRING… * Advanced degree (PhD or Masters) * Minimum 6 years eCTD submission 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 for efficacy or safety clinical summary modules and drug applications across different regions. * Proven experience leading stakeholders/project teams through submission document development. * 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 partner´s team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas. A UNIQUELY DIVERSE CAREER At Fortrea, your career path is yours to shape. We empower our team to steer their own development. Where are you in your career journey? * 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. Your aspirations drive your journey with us. US ONLY: Pay Range: $125,000 - $145,000 USD Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here. Application Deadline: November 15, 2024. 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 www.fortrea.com. 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. 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