Medical Writer II​/Medical Writer III

Organizational Overview:

TG Therapeutics is a fully-integrated, commercial-stage, biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the United States Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) in the US and European Commission.

The Medical Writer function plays a critical role in developing high-quality clinical, regulatory, and scientific documents to support global drug development programs. This role is responsible for authoring and leading clear, accurate, and submission-ready documentation aligned with regulatory expectations.

The Medical Writer collaborates closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Biostatistics, and Safety, to ensure documentation is scientifically robust, strategically aligned, and compliant.

This role is intended for experienced medical writing professionals (Medical Writer II or III) with demonstrated ability to independently manage documents and, at the senior level, lead complex deliverables and provide strategic input across studies or programs. The role will report to the VP, Program Management, with the potential to start as a 6‑month contract‑to‑hire position or be a full‑time position.

Document Development & Ownership

• Independently author, edit, and manage clinical, regulatory, and scientific documents, including protocols, clinical study reports, investigator brochures, briefing documents, submission components, and related deliverables
• Translate complex clinical, scientific, statistical, and regulatory information into clear, concise, and well‑structured documents
• Ensure accuracy, consistency, and traceability of data across documents, including appropriate source‑data verification

Project & Timeline Management

• Develop and manage document timelines and deliverables in alignment with study and program milestones
• Lead or support document planning, cross‑functional review cycles, and comment resolution
• Manage multiple concurrent writing projects while proactively identifying risks and dependencies

Cross‑Functional Collaboration

• Partner with cross‑functional teams to align on document strategy, messaging, and data presentation
• Integrate input from multiple stakeholders to produce high‑quality, submission‑ready deliverables
• Collaborate with external contributors, including contract writers, vendors, and consultants as needed

Quality & Compliance

• Ensure documents comply with regulatory requirements, ICH guidelines, and company standards
• Apply strong editorial judgment to improve clarity, structure, and consistency
• Maintain version control, documentation, and audit‑ready records to support inspection readiness

Process Improvement

• Contribute to development and refinement of templates, style guides, and writing processes
• Support continuous improvement of medical writing standards and operational efficiency

Leadership & Strategic Contribution (primarily Medical Writer III)

• Lead complex or high‑priority writing projects and cross‑functional initiatives
• Provide strategic input on document messaging, organization, and regulatory positioning
• Ensure consistency and alignment across multiple documents within a study or submission
• Review and provide substantive feedback on work from other writers
• Identify risks and proactively recommend solutions related to documentation, timelines, or content gaps
• Oversee vendors or contract writers, as applicable

• 2–4 years (Medical Writer II) or 5+ years (Medical Writer III) of relevant experience in medical writing, regulatory writing, clinical development, or scientific communications within the biotechnology or pharmaceutical industry
• Demonstrated experience authoring clinical and regulatory documents (e.g., clinical study reports, protocols, investigator brochures, submission documents, or manuscripts)
• Strong ability to interpret and translate complex clinical, scientific, and statistical data into clear, accurate, and well‑structured written content
• Working…