Senior Medical Writer

Job not on LinkedIn

🕒 March 25

🇺🇸 United States – Remote

💵 $130k - $150k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🧬 Biotechnology

⚕️ Healthcare Insurance

🔬 Science

Biotechnology • Healthcare Insurance • Science

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• Implements all activities related to the preparation of defined medical and regulatory documents. • Supports documents for regulatory submissions to US and global health authorities. • Collaborates with cross-functional team members to ensure accurate and timely completion of documents. • Supports clinical trial transparency and disclosures, including clinical trials registration and results posting. • Contributes to departmental development through editorial and review support for document templates and style standards. • Ensures adherence to relevant SOPs and internal best practices.

🎯 Requirements

• Bachelor’s degree required within a scientific discipline. • 4+ years of medical writing experience in Sponsor or CRO setting. • AMWA certification preferred. • Experience using medical writing systems and technologies including Veeva RIM. • Knowledge of drug development, study conduct processes, ICH guidelines, and FDA/EU guidance. • Highly organized and detail-oriented with a passion to deliver quality results quickly. • Strong verbal and written communication skills with an ability to build relationships internally and externally. • Highest levels of professionalism, confidence, personal values, and ethical standards.

🏖️ Benefits

• 99% of the premium paid for medical, dental and vision plans. • Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. • 401(k) matching dollar-for-dollar up to 6% on eligible contributions. • Long-term stock incentives and ESPP. • Discretionary quarterly bonus. • Extremely flexible wellness benefit. • Generous PTO, paid holidays and company-wide shutdowns.