Medical Writer (Remote) - Theradex Oncology

Celebrating 40+ Years!

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.   

Medical Writer (Oncology Clinical Trials) Remote US

We are seeking a full-time remote Medical Writer to join our team. If you have 2+ years of oncology medical writing experience with a pharmaceutical company or CRO and want to develop and grow your career even further, then this is the opportunity for you.

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 brochures and updates
  • Interim and final clinical study reports
  • IND annual report / 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
• Support electronic submission of regulatory documents to the FDA

Level of Education

• Bachelor’s degree required / Advanced degree preferred

Prior Experience

• 2+ years prior relevant experience in a CRO/pharmaceutical environment

Skills and Competencies

• Familiarity with industry principles of drug safety, US and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology
• Effective knowledge of company and sponsor-specific SOPs
• Ability to 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

What We Offer

We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.   

Theradex is an Equal Opportunity Employer.

Theradex is not utilizing agencies for this role. Unsolicited resumes will not be accepted.