Senior Medical Writer

Theradex Oncology is recruiting a Senior Medical Writer with 5+ years of experience to join their team. The primary responsibilities include preparation of IND applications, clinical study protocols, and other regulatory documents.

Requirements

• Bachelor’s degree required / Advanced degree preferred
• 5+ years prior experience in a CRO/pharmaceutical environment
• 3+ years prior relevant experience in regulatory Medical Writing (oncology experience preferred)
• Lead writer experience on at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Development Safety Update Reports, IND applications, Informed Consent forms.
• Experience working directly with clients/Sponsors, preparing document timelines, organizing review cycles, and coordinating review meetings
• Familiarity with industry principles of drug safety, EU, US and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology
• Effective knowledge of company and sponsor-specific SOPs
• Ability to work independently, meet deadlines and be results-oriented
• Ability to manage critical issues on multiple projects simultaneously
• Function as a team-player, highly organized, self-motivated, and extremely detail-oriented
• Strong oral and written communication skills, excellent interpersonal skills, and advanced computer literacy of MS Office Suite

Benefits

• Competitive compensation and benefits package
• Friendly and supportive culture that puts people first