Description review
Senior PSUR Writer
CooperSurgical · United States · back to the listing
HR standards
44/100
poor
Title ↔ description
78/100
solid
Reads as
Technical Writer
91% confident
What this role officially is
technical communicator — ESCO, the EU occupation classification
Technical communicators prepare clear, concise and professional communication from product developers to users of the products such as online help, user manuals, white papers, specifications and industrial videos. For this, they analyse products, legal requirements, markets, customers and users. They develop information and media concepts, standards, structures and software tool support. They plan the content creation and media production processes, develop written, graphical, video or other contents, generate media output, release their information products and receive feedback from the users.
Also known as: technical editor, technical documentation author, senior technical communicator, technical communicators, technical content developer, user experience designer
How others title the same work
Large employers
- Technical Author (multiple roles and seniority levels) Canonical Ltd.
- Manager I, Documentation Datadog
What the listing never says
- No section describes what the person would actually do. Scope clarity
- No pay range published. Candidates cannot tell whether applying is worth their time. Pay transparency
The listing, marked up
Nothing in the wording of this listing tripped a check. The scores above still judge how complete and coherent it is.
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 women’s 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 .
Work location: Remote in US
Job Summary:
The Sr. PSUR Writer is responsible for leading the development, review, and submission readiness of Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs) for global medical device portfolios. This role serves as a subject matter expert in post-market surveillance documentation and regulatory requirements, provides strategic input regarding safety trends and risk-benefit evaluations, and supports junior writers while ensuring timely compliance with domestic and international regulations.
Originally posted on Himalayas
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 women’s 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 .
Work location: Remote in US
Job Summary:
The Sr. PSUR Writer is responsible for leading the development, review, and submission readiness of Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs) for global medical device portfolios. This role serves as a subject matter expert in post-market surveillance documentation and regulatory requirements, provides strategic input regarding safety trends and risk-benefit evaluations, and supports junior writers while ensuring timely compliance with domestic and international regulations.
Originally posted on Himalayas