Job Description
Who We Are Celebrating 40+ years!
Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.
What You'll Do As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will the work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.
Opportunity
Senior Medical Writer 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 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 At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $110,000-$140,000 with bonus potential.The actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role.
This position is not eligible for company provided sponsorship or relocation.
Theradex is an Equal Opportunity Employer.
Job Tags
Interim role, Relocation, Flexible hours,