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The era of genetic neuroscience has arrived
Senior Medical Writer - US
Location
United States
Posted
85 days ago
Salary
$130K - $150K / year
Seniority
Senior
No structured requirement data.
Job Description
Senior Medical Writer - US
Praxis Precision Medicines, Inc.
Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity 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. Primary 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 Qualifications and Key Success Factors - 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 - 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 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. Compensation & Benefits At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together! To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience. Annualized Base Salary $130,000—$150,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
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• 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.
Traveling Nurse Educator - Live NCLEX Review Presenter
UWorldWe make really hard stuff easy to understand. Customizable learning tools for key exams + teaching tools for educators.
Traveling Nurse Educator – Live NCLEX Review Presenter Department: Nursing Education Location: Travel-Based (5–6 trips annually) Position Summary UWorld is seeking an experienced and engaging Nurse Educator to deliver live, onsite NCLEX review presentations for nursing programs nationwide. This individual will serve as an educational ambassador for our organization, providing high-quality instruction that supports student understanding, builds confidence, and promotes NCLEX exam success. Key Responsibilities - Travel to nursing programs across the country to present live NCLEX review sessions. - Deliver high-impact instructional workshops using evidence-based teaching methods. - Present clinical concepts clearly, accurately, and in a manner that is easy for students to understand. - Motivate and support nursing students as they prepare for the NCLEX. - Represent UWorld with professionalism and uphold organizational values. - Collaborate with internal teams to maintain content accuracy and instructional alignment. Qualifications - Current, unrestricted RN license. - MSN required. - Demonstrated teaching experience (clinical, classroom, or NCLEX preparation strongly preferred). - Exceptional communication and presentation skills. - Ability to simplify complex topics and actively engage diverse learners. - Flexibility to travel on a periodic basis (approximately 5–6 trips per year). - Commitment to educational excellence and the success of future nurses. Why Join UWorld? - Competitive compensation and travel reimbursement. - Opportunities to travel and connect with nursing faculty and students nationwide. - Meaningful, mission-driven work that directly impacts NCLEX readiness. - A dynamic, collaborative environment with supportive leadership.
Senior Medical Writer
Telix Pharmaceuticals LimitedDeveloping theranostics (nuclear medicine) for prostate, kidney, glioblastoma, haematologic cancers and rare diseases.
• Lead the compilation, writing, and editing of high-quality clinical study synopses, minutes of advisory boards and study steering committees, and clinical sections of regulatory documents • Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions and compose text accordingly. • Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed. • Maintain working knowledge of the Telix clinical development pipeline. • Prepare, review, and edit clinical documents including, but not limited to, clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), and regulatory submission documents (e.g., INDs, NDAs, BLAs, CTDs). • Ensure all documents comply with regulatory guidelines, company standards, and industry best practices. • Lead and manage multiple medical writing projects simultaneously, ensuring timely delivery of high-quality documents. • Coordinate with cross-functional teams to gather necessary information and resolve any issues that arise during the document development process. • Conduct thorough reviews of documents for accuracy, consistency, and clarity as needed. • Work closely with clinical development teams, including clinical operations, regulatory affairs, biostatistics, physicians, and medical affairs, to ensure alignment and accuracy of clinical documents. • Provide medical writing expertise and support to project teams, contributing to strategic planning and decision-making. • Mentor and train junior medical writers, providing guidance and support to enhance their skills and career development, along with oversight to external contractors. • Stay current with industry trends, guidelines, and best practices, and share knowledge with the team. • Support regulatory submissions by preparing high-quality documentation and addressing health authority comments and queries. • Ensure compliance with regulatory requirements and timelines for all submission-related activities.
