Praxis

Compliance

• Support the development and execution of global regulatory strategies for ongoing clinical-stage programs, with a strong focus on lifecycle management.
• Lead regulatory activities for clinical development programs, including new IND submissions, protocol amendments, annual reports, safety updates, and global CTA maintenance.
• Partner with Clinical Development, Nonclinical, CMC, and Translational teams to align regulatory strategy with evolving development objectives and timelines.
• Prepare and manage regulatory submissions (e.g., IND amendments, new INDs, CTAs, briefing packages) in collaboration with internal stakeholders and external vendors.
• Contribute to preparation for and participation in health authority interactions (e.g., FDA, EMA, MHRA), including meeting strategy, briefing document preparation, and response coordination.
• Provide regulatory guidance to cross-functional teams on clinical trial design, patient selection, and regulatory requirements to support lifecycle activities.
• Support planning for future marketing applications by ensuring development programs are conducted in alignment with global registration requirements.
• Monitor and interpret evolving regulatory guidance and communicate potential impact on ongoing programs.
• Contribute to regulatory intelligence efforts and continuous improvement of regulatory processes.

Senior Manager, Regulatory Strategy

Program Manager

• Operationalize the HUB: Stand-up core PSP operations including intake pathways, SOPs, training materials, call guides, FAQs, and quality controls.
• Translate strategy into execution: Implement program design, pressure-test workflows, and ensure processes perform reliably in real-world conditions.
• Partnership & Collaboration: Ensure clear, consistent handoffs across HUB, field teams, and vendor partners.
• Ensure systems support operations: Ongoing engagement with technology partners to ensure tools are configured and function to support workflows; identify and resolve gaps quickly.
• Establish and manage performance standards: Define SLAs, monitor performance, conduct root-cause analysis, and hold teams and vendors accountable.
• Lead day-to-day operations: Lead onboarding, training, and ongoing performance management to drive consistent, high-quality execution.
• Drive data integrity and visibility: Define reporting needs and ensure accurate case documentation and data capture to enable visibility into performance, access barriers, and risk.
• Embed compliance into execution: Ensure HIPAA adherence, audit readiness, and appropriate controls across all workflows in partnership with Legal and Compliance.
• Own launch readiness: Identify operational gaps early, prioritize fixes, and ensure the program is fully functional and resilient for launch readiness.

Lead, Patient Support Program Operations

Manager

• Design, implement, and maintain company-wide stage-appropriate Quality Systems aligned with GxP principles.
• Regularly assess and enhance GxP practices to meet evolving regulations.
• Collaborate with cross-functional teams to drive GxP excellence.
• Provide training on GxP requirements to personnel at all levels.
• Provide coaching on Quality best practices and procedures.
• Support implementation and training on new quality processes.
• Conduct compliance risk assessments and trend analysis.
• Support oversight of the Supplier Quality Management program, Training, and Document Control.
• Ensure adequate/approved suppliers and vendors are utilized by the company.
• Establish, compile, track, and present Quality Metrics for Quality Management Review.
• Provide input into decisions for change management and CAPA programs.
• Support inspection readiness activities, including participation in audits.

Quality Systems Manager

Engineer

• Understand varied formulation processes and transfer drug product processes for industrialized execution by authoring scale up spreadsheets and process manuals
• Efficiently use technologies and applications to gather, analyze and archive large data packages that can support regulatory filings
• Review relevant documentation from CMOs and lab partners including instructions, procedures, batch records, non-conformances, in-process controls, bulletin of analysis, developmental reports
• Work alongside Quality Assurance to ensure all proper regulations and standards are followed in all processes being executed by third parties
• Adhere to industry guidelines, standards and laws including being well-versed in cGMPs
• Travel required - PIP at CMOs (US and worldwide)

Senior Manager, Process Engineer – Drug Product

Director

• Serve as the Medical Affairs leader for Neurology, representing Praxis internally and externally with KOLs, investigators, and advocacy organizations.
• Lead the development and execution of integrated medical strategy across the product lifecycle.
• Shape disease-state strategy, scientific exchange, and evidence generation plans.
• Design and execute key initiatives including advisory boards, congress strategy and engagement, publication planning, field medical strategy.
• Build and maintain strong relationships with external stakeholders, including KOLs, academic institutions, and patient advocacy groups.
• Partner cross-functionally with Clinical Development, Commercial, Regulatory, and other key functions to ensure alignment and impact.
• Lead Investigator-Initiated Studies (IIS) and company-sponsored research strategy.
• Oversee vendors, budgets, and operational execution with a focus on quality and compliance.

Senior Director, Medical Affairs – Neurology/CNS

Medical writer

• 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.

Senior Medical Writer

• Serve as the U.S. facing PV leader, ensuring timely follow-up on safety actions across global teams and time zones.
• Own oversight of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and continuous process improvement.
• Contribute to the development and evolution of PV SOPs, safety management plans, and database migrations.
• Support signal detection activities, literature review, aggregate report preparation, and safety governance meetings.
• Prepare and/or QC safety narratives, regulatory safety responses, IND/NDA/MAA components, and DSMB materials.
• Collaborate with Clinical Operations, Regulatory, Medical Affairs, Commercial, and Quality.

Associate Director, PV Scientist

• Serve as the Medical Affairs leader for the therapeutic area, both internally and externally.
• Lead the development and execution of integrated medical brand and disease-state strategies.
• Proactively build and manage relationships with healthcare professionals, academic institutions, and patient advocacy organizations.
• Partner cross-functionally with Marketing, Business Insights, Business Development, Finance, Legal, and other functions.
• Develop and execute Medical Affairs plans, including publication planning and scientific conferences.

Senior Director, Medical Affairs – Epilepsies Lead

• Define and execute the Medical Affairs strategy for Movement Disorder therapeutic area.
• Lead Medical Affairs enabling functions including operational execution, vendor oversight, and budget management.
• Establish and maintain relationships with key opinion leaders and advocacy organizations.
• Collaborate cross-functionally to ensure alignment with corporate objectives.
• Develop and execute Medical Affairs plans including publication planning and educational programs.
• Oversee external vendors for timely execution.

Senior Director, Medical Affairs – Movement Disorders Lead

Analytics Engineer

• Design, develop, and maintain scalable ETL/ELT pipelines that support cross-functional data needs
• Build, deploy, and optimize Power BI dashboards and other reporting tools to support strategic decision-making
• Write well-structured, testable code in Python, R, and SQL to support analytics workflows
• Lead the development and enforcement of version control, documentation, and coding standards
• Partner with data scientists to bring analytics products from prototype to production
• Identify and integrate AI-driven tools to enhance data processing and reporting capabilities
• Mentor junior team members and contribute to a culture of knowledge sharing and continuous improvement

Data & Analytics Engineer II

• Own and manage the configuration, deployment, and optimization of Microsoft Intune across all corporate devices
• Own and understand dynamic software patching and deployment of patching using modern tools
• Administer and troubleshoot Microsoft Entra (Azure AD) to support secure access and identity management
• Develop and enforce device compliance policies, ensuring security standards are met across endpoints
• Partner with IT leadership to refine endpoint strategy and tooling as we scale
• Proactively monitor, detect, and remediate issues impacting device health, performance, or security
• Build and maintain documentation, SOPs, and automated workflows for efficiency and consistency
• Serve as a go-to resource for device-related escalations and user support