Location: Morrisville, NC (remote)
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Organizational Overview
TG Therapeutics is a fully integrated, commercial stage, biotechnology 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 U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.
Role
The Medical Writing 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.
Key Responsibilities
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
Professional Experience/Qualifications
- 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 knowledge of drug development processes, clinical research, and regulatory requirements, including familiarity with ICH guidelines
- Proven ability to independently manage writing projects, timelines, and cross-functional input
- Experience leading complex or multi-document deliverables or supporting regulatory submissions (e.g., NDAs, BLAs, MAAs)
- Ability to provide strategic input on document messaging, organization, and regulatory positioning
- Experience ensuring cross-document consistency and submission readiness across studies or programs
- Prior experience mentoring junior writers or reviewing the work of others
- Experience managing or overseeing external vendors or contract medical writers
- Therapeutic area experience in neurology, immunology, autoimmune disease, multiple sclerosis, or related areas
- Familiarity with document management systems, collaborative authoring tools, and emerging technologies (e.g., AI-enabled writing tools)
Education
- Bachelor’s degree in life sciences, health sciences, pharmacy, or a related discipline required; advanced degree (e.g., MS, PhD, PharmD) preferred
Applicants must be currently authorized to work in the United States on a full-time basis. The company does not sponsor employment visas for this position.
TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.
