PSUR Writer II

CooperSurgical; Trumbull (CT); Teletrabalho; USD 75 000 - 100 000; Tempo integral

Resumo da oferta

CooperSurgical is seeking a PSUR Writer II to prepare, maintain, and timely complete PMSPs, PMSRs, and PSURs, ensuring compliance with global regulatory requirements. You will gather data from Clinical, Regulatory, Risk, and Quality teams and summarize safety information for regulatory submissions.

You will analyze data, support literature reviews, and help improve PMS/PSUR processes, templates, and guidance, contributing as a regulatory documentation expert within a collaborative,

Qualificações

• 3+ years experience in Quality Assurance, Regulatory Affairs, Pharmacovigilance, Medical Writing, or related medical device functions.
• Experience supporting PMS Plans, PSURs, PMSRs, CERs, or related regulatory documents.
• Bachelor's degree in a scientific, technical, engineering, healthcare, or related discipline.
• Strong written and verbal communication skills.

Responsabilidades

• Author and maintain PMS documentation including PMSPs, PMSRs, and PSURs for assigned product portfolios.
• Gather and compile information from Clinical Affairs, Regulatory Affairs, Risk Management, Marketing, Quality, and other stakeholders.
• Analyze and summarize post-market surveillance, complaint, vigilance, clinical, and risk management data to develop regulatory-compliant safety summaries and trend analyses.
• Support literature reviews and post-market surveillance activities.
• Conduct public database searches for adverse events, recalls, and competitor safety information.
• Perform data collection, quality checks, and basic analysis to support PSUR development.
• Review, trend, and analyze relevant safety and performance data to support conclusions documented within PMSRs and PSURs.
• Maintain documentation within the Quality Management System.
• Proactively identify potential timeline, quality, or data risks affecting assigned reports and communicate mitigation plans to management.
• Contribute to the development, maintenance, and continuous improvement of PMS and PSUR-related procedures, work instructions, templates, and guidance documents.
• Identify opportunities to improve document quality, consistency, and efficiency within PMS reporting processes.
• Ensure documentation is maintained in accordance with Quality Management System requirements and current regulatory expectations.
• Support EU MDR compliance activities related to PMS documentation.
• Participate in cross-functional meetings and project discussions.
• Perform other duties as assigned.

Conhecimentos

Quality Assurance

Regulatory Affairs

Pharmacovigilance

Medical Writing

Formação académica

Bachelor's degree

Ferramentas

Microsoft Word

Microsoft Excel

Microsoft Teams

SharePoint

Descrição da oferta de emprego

JOB DESCRIPTION

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to womens and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to womens and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

Work location

Remote in US

Job Summary

The PSUR Writer II is responsible for the preparation, maintenance, and timely completion of Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs) to ensure compliance with global regulatory requirements. The role collaborates cross-functionally to gather relevant safety, clinical, complaint, vigilance, and risk management information; evaluates and summarizes data; and ensures documentation is completed in accordance with applicable regulatory requirements and internal timelines. The PSUR Writer II contributes to process improvements, supports the development of departmental procedures and templates, and serves as a knowledgeable resource for post-market surveillance documentation activities.

Responsibilities

• Author and maintain PMS documentation including PMSPs, PMSRs, and PSURs for assigned product portfolios.
• Gather and compile information from Clinical Affairs, Regulatory Affairs, Risk Management, Marketing, Quality, and other stakeholders.
• Analyze and summarize post-market surveillance, complaint, vigilance, clinical, and risk management data to develop regulatory-compliant safety summaries and trend analyses.
• Support literature reviews and post-market surveillance activities.
• Conduct public database searches for adverse events, recalls, and competitor safety information.
• Perform data collection, quality checks, and basic analysis to support PSUR development.
• Review, trend, and analyze relevant safety and performance data to support conclusions documented within PMSRs and PSURs.
• Maintain documentation within the Quality Management System.
• Proactively identify potential timeline, quality, or data risks affecting assigned reports and communicate mitigation plans to management.
• Contribute to the development, maintenance, and continuous improvement of PMS and PSUR-related procedures, work instructions, templates, and guidance documents.
• Identify opportunities to improve document quality, consistency, and efficiency within PMS reporting processes.
• Ensure documentation is maintained in accordance with Quality Management System requirements and current regulatory expectations.
• Support EU MDR compliance activities related to PMS documentation.
• Participate in cross-functional meetings and project discussions.
• Perform other duties as assigned.

Travel

This position may require 0-5% domestic and/or international travel.

Qualifications

Knowledge, Skills and Abilities

• Strong written and verbal communication skills.
• Basic understanding of EU MDR, FDA regulations, and medical device vigilance requirements.
• Ability to summarize technical and scientific information clearly.
• Strong organizational and time-management skills.
• Detail-oriented with strong document review capabilities.
• Proficiency with Microsoft Word, Excel, Teams, and SharePoint.
• Basic understanding of Quality Management Systems.
• Ability to work effectively in a cross-functional team environment.

Work Environment

• Prolonged periods of sitting, especially in front of a computer.

Experience

• 3+ years experience in Quality Assurance, Regulatory Affairs, Pharmacovigilance, Medical Writing, or related medical device functions.
• Experience supporting PMS Plans, PSURs, PMSRs, CERs, or related regulatory documents preferred.

Education

• Bachelor's degree required in a scientific, technical, engineering, healthcare, or related discipline.

Our Benefits

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $75,000.00 - $100,000.00 annually. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.