Open Position
Title: Medical Writer, Global Program Management
Location: 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, 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 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
Author of high-quality protocols and reports pertaining to clinical studies and health authority communications and submissions. The Medical Writer will prepare 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. The Medical Writer will participate in clinical analyses and prepare strategic documents such as clinical overviews, briefing packages and responses for regulatory agencies. 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, and other clinical regulatory 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 lean and 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 document preparation process and 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.