Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide 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.
Write and Review Safety Reports: Prepare various safety reports for global regulatory submissions including, but not limited to:
Lead Report Production: Oversee the end-to-end process of report production ensuring required quality standards and key timelines are met. Provide oversight to co-authors or a team of writers and be accountable for the quality of their work.
Primary Point of Contact: Act as the main contact for clients for all report management activities. Manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables.
Safety/Benefit-Risk Review Meetings: Participate in meetings with clients to discuss results and conclusions from signal/safety analysis. Collaborate with the safety physician to propose label updates and other risk mitigation measures.
Project Management Activities: Support activities such as maintenance of project schedules and tracking of metrics and compliance.
Business Development: Contribute to business development activities, including estimation of resource requirements and responding to RFPs.
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. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and qualifications, without regard to race, religion, color, national origin, gender, family status, sexual orientation, age, veteran status, disability, 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.
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