What are the responsibilities and job description for the Senior Medical Writer position at Theradex Oncology?
Who We Are
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.
What You'll Do
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.
Remote: US
The primary responsibilities of this position include, but are not limited to, preparation of the following:
- 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
- Support electronic submission of regulatory documents to the FDA
- Serve as a resource for new medical writers
What You Need
Level of Education
- Bachelor’s degree required / Advanced degree preferred
Prior Experience
- 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 eCTD modules
Skills and Competencies
- 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 verbal and written communication skills, excellent interpersonal skills, and advanced computer literacy of MS Office Suite
What We Offer
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.
NOTE: Theradex is not utilizing agencies for this role. Unsolicited resumes will not be accepted.
