Job Title: Lead Safety Report Writer
Company: Fortrea, a Global Contract Research Organization (CRO)
Location: [Insert Location]
Job Overview:
Fortrea, a leading global contract research organization (CRO), is seeking a Lead Safety Report Writer to take a leadership role in the preparation and review of safety, risk management, signal detection, and benefit-risk evaluation reports. In this position, you will be responsible for managing complex data analyses and safety issues, providing technical leadership across projects, and ensuring the delivery of high-quality scientific content. You will collaborate with clients and internal teams to manage stakeholder expectations, resolve issues, and meet tight timelines while contributing to scientific publications and representing Fortrea at industry events. This role is integral to driving quality improvements within clinical development processes.
Summary of Responsibilities:
Lead Safety Reporting: Write and review various safety reports for global regulatory submissions, including but not limited to:
Report Production Oversight: Lead the end-to-end process of report production, ensuring quality standards and timelines are met. Provide oversight and quality control to co-authors and writing teams.
Client Communication: Serve as the primary point of contact for clients on all report management activities. Manage client expectations, resolve project issues, and escalate as needed to ensure deliverables meet required standards.
Risk Management and Signal Detection: Author/review Risk Management Plans (RMPs), Benefit-Risk Evaluation reports, and other risk-related documentation. Participate in signal management processes, developing strategies, retrieving data from safety databases, and preparing signal evaluation reports.
Scientific Contributions: Draft responses to health authority questions, contribute to scientific publications, and present at conferences. Develop abstracts, posters, and manuscripts for publication in scientific forums.
Team Leadership and Mentorship: Act as a writing coach, providing regular feedback, conducting training, and promoting adherence to style guides and best practices within the writing team.
Project Management Support: Assist in maintaining project schedules, tracking metrics, and ensuring compliance with project timelines and quality requirements.
Business Development: Contribute to business development activities, including resource estimation and responding to RFPs.
Regulatory Compliance: Ensure that all operations comply with governing regulatory requirements and contribute to the development of consistent, efficient processes.
Qualifications (Minimum Required):
Education: A first degree in life sciences (or equivalent). Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience:
Skills:
Preferred Qualifications:
Physical Demands/Work Environment:
Fortrea is an Equal Opportunity Employer:
As an Equal Opportunity Employer, Fortrea promotes diversity and inclusion in the workforce. We do not tolerate harassment or discrimination of any kind. Employment decisions are based on the needs of the business and the qualifications of the individual. We encourage all individuals to apply.
For more information on how we collect and store personal data, please see our Privacy Statement.
If you require reasonable accommodation to complete your job application, pre-employment testing, or to participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this email is for job seekers requesting accommodations only.
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