Senior Medical Writer - US

Praxis Precision Medicines, Inc.

2d • $130,000 - $150,000 • Remote

About The Position

This role is responsible for medical writing activities for one or more clinical development programs at Praxis, as directed by the Associate Director, Medical Writing. The individual will complete accurate, high quality, and regulatory compliant documents in support of clinical trials and regulatory submissions. This position requires the knowledge and expertise to collaboratively author required documents with support from the Associate Director, Medical Writing while also helping teams follow medical writing processes and style requirements.

Requirements

• Bachelor’s degree required within a scientific discipline, advance degree, CNS, and Rare Disease experience a plus
• 4+ years of medical writing experience in Sponsor or CRO setting
• Knowledge of drug development, study conduct processes, ICH guidelines, and FDA/EU guidance or demonstrated success within a regulated industry environment
• 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
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Nice To Haves

• AMWA certification preferred
• Experience using medical writing systems and technologies including Veeva RIM

Responsibilities

• Implements all activities related to the preparation of defined medical and regulatory documents, serving as writing lead on assigned documents or identifying when external writers are necessary for support
• Supports documents for regulatory submissions to US and global health authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), protocols, investigator brochures, clinical study reports, briefing documents, regulatory responses to health authority questions, and scheduled reports.
• Collaborates with cross-functional team members, eg, Clinical Pharmacology, Toxicology, Research, Clinical Development, Regulatory Affairs, Biostats, Data Management, Quality, CMC, QC, etc., to ensure accurate and timely completion and delivery of high-quality, scientifically-sound documents, slide decks, and publications
• Supports clinical trial transparency and disclosures, including clinical trials registration and results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide
• Contributes to departmental development through editorial and review support for document templates, style standards, reviewer guidelines, and standard operating procedures to ensure consistent and high-quality deliverables
• Ensures adherence to relevant SOPs and internal best practices

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
• dollar-for-dollar match up to 6% on eligible 401(k) contributions
• long-term stock incentives and ESPP
• discretionary quarterly bonus
• extremely flexible wellness benefit
• generous PTO, paid holidays and company-wide shutdowns

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees