[Hiring] Senior Medical Writer @Theradex Oncology

Role Description

Theradex is recruiting for a highly collaborative Senior Medical Writer with 5+ years experience to join our team. If you are a self-starter and want to be part of the full life-cycle of the regulatory medical writing process, this opportunity may be for you.

The Senior Medical Writer will be part of the growing team within Theradex and have a client facing, collaborative role with direct involvement with medical monitors and senior leadership.

The primary responsibilities of this position include, but are not limited to, the following:

• Preparation of Initial Investigational New Drug (IND) applications and amendments
• Clinical study protocols and protocol amendments
• Investigator's brochures and updates
• Interim and final clinical study reports
• IND annual reports
• Development safety update reports
• Patient informed consent forms
• Provide guidance and support to other in-house units in preparation or review of manuals, training guidelines and similar documents
• Serve as a resource for new medical writers

Qualifications

• 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 required)
• Lead writer experience on >3 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Development Safety Update Reports, IND applications
• Experience collaborating directly with clients/Sponsors, preparing document timelines, organizing review cycles, and coordinating review meetings
• Proven experience with Fast Track Applications: INDs/BTDRs
• Familiarity with eCTD modules
• Familiarity with industry principles of drug safety, US and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology
• 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

• Friendly and supportive culture that puts people first
• Competitive compensation and benefits package as per country requirements

Company Description

Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.