Senior Medical Writer

Job not on LinkedIn

🕒 May 8

🦌 Connecticut – Remote

🦌 Connecticut – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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CooperCompanies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1978

⚕️ Healthcare Insurance

🧬 Biotechnology

☁️ SaaS

💰 Post-IPO Equity on 2021-12

Healthcare Insurance • Biotechnology • SaaS

CooperCompanies is a global, consumer-centric medical device company that supports how people want to live at every stage of life. The company is dedicated to improving lives by listening closely to healthcare providers and patients to fulfill the needs of today while focusing on the opportunities of tomorrow through innovation and strategic investment. Their prominent divisions, CooperVision and CooperSurgical, are committed to addressing issues such as myopia in children and supporting families struggling with infertility. CooperCompanies actively engages in sustainable practices and seeks to elevate standards of care with a strong focus on social and environmental impact.

📋 Description

• - Author and edit clinical documents, including Clinical Evaluation Reports (CERs), literature reviews, and regulatory submissions. • - Plan and report clinical data collection for PMCF and clinical trials nationally and internationally. • - Ensure clinical documentation compliance with EU MDR, FDA, and other international regulatory requirements. • - Collaborate with Global Regulatory & Clinical Affairs teams to maintain clinical documentation within the Quality Management System. • - Stay updated on scientific literature and regulatory changes within the company’s therapeutic area. • - Participate in cross-functional projects and contribute to clinical strategy and documentation planning. • - Support Medical Affairs for literature reviews and writing of documentation

🎯 Requirements

• - **Knowledge, Skills, and Abilities:** • - Strong understanding of EU MDR, FDA regulations, and ISO standards for medical devices. • - Proficiency in document management systems and Microsoft Office Suite • - Excellent written and verbal communication skills • - Ability to interpret clinical data and present findings clearly • - Analytical mindset • - Detail-oriented, organized, and results-driven • - **Experience:** • - Preferred 5-10 years of experience in medical writing for medical devices, including CERs and PMCF documentation. • - **Education:** • - Master’s degree in Life Sciences or related field preferred.

🏖️ 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.