Senior Medical Writer

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 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. Remote: UK, Sweden, Denmark & Netherlands The 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. Key Responsibilities 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. What You Need 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 What we offer: 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.