Title Senior Medical Writer

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.

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 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.

Theradex is recruiting a highly collaborative Senior Medical Writer (Permanent, Full‑time) with 5+ years of experience to join our team. If you are a self‑starter who wants to contribute across the full life cycle of the regulatory medical writing process, this opportunity may be an excellent fit.

Senior Medical Writer will be an integral member of our growing medical writing group and will take on a client‑facing, collaborative role with direct engagement alongside medical monitors and senior leadership. In this position, you will contribute to high‑quality clinical and regulatory documentation, support strategic discussions, and help shape the scientific narrative across multiple projects. The role offers meaningful visibility within the organization and requires someone who thrives in a dynamic environment, partners effectively with cross‑functional experts, and represents the medical writing function with professionalism and confidence.

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

Regulatory submissions — 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 (CSRs)
• IND Annual Reports
• Development Safety Update Reports (DSURs)
• Patient Informed Consent Forms (ICFs)

Cross‑functional support — Provide guidance and support to other in‑house units in the preparation or review of manuals, training guidelines, and similar documentation.

Mentorship — Serve as a resource for new medical writers, offering direction, feedback, and support as needed.

• 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

We offer a friendly and supportive culture that puts people first. You will be provided with competitive compensation and benefits package as per country requirements.

This job does not offer company sponsorship

Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.