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Open Position
Title: Medical Writer, Global Program Management
Location: Remote
If you are interested in the below position, please send your resume to careers@tgtxinc.com and REFERENCE THE POSITION TITLE within the subject line.
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. 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). For more information, visit www.tgtherapeutics.com.
Role
The Medical Writer will author high-quality protocols and reports pertaining to clinical studies and health authority communications and submissions. This role involves preparing clinical regulatory documents, including clinical study protocols, reports, and summaries in close collaboration with TG Therapeutics (TGTX) development teams to ensure timely completion of high-quality documents. Reports to VP, Global Program Management.
Key Responsibilities
- Lead medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and filings.
- Write, edit, and review clinical study protocols and reports, manuscripts, investigator brochures, registration dossier modules, health authority communications, and briefing documents.
- Prepare regulatory clinical documentation in collaboration with TGTX development teams.
- Lead initiatives to improve medical writing processes, standards, and initiatives.
- Proofread and edit scientific and technical content to ensure adherence to approved style guides.
- Solve complex problems associated with medical writing across departments and teams.
- Translate complex information from subject-matter experts into clear text; able to draft documents from templates, drafts, and synopses.
Professional Experience/Qualifications
- Experience in the biopharmaceutical industry; advanced degree, academic research, or other transferrable skills may be considered in lieu of industry experience.
- 3 years of medical writing experience.
- Therapeutic area knowledge and expertise on requirements for clinical/regulatory documents.
- Expert understanding of the document preparation process and the role of each contributing function.
- Ability to work cross-functionally to develop document preparation plans, proactively identify risks, develop risk-mitigation strategies, communicate team decisions, and document status.
- Ability to work in a fast-paced, remote environment with internal and external team members with changing priorities and deadlines.
- Thorough knowledge and understanding of Health Authority regulations, guidance documents, and the drug development process.
- Committed to process improvement and good documentation practices.
- Proficient with MS Office and Adobe Acrobat.
Education
Bachelor’s degree in life sciences or health discipline required; advanced degree preferred.
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.
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