Job Posting Title Senior Medical Writer

Theradex Systems, Inc.; United Kingdom; A distancia; GBP 65.000 - 90.000; Jornada completa

Descripción de la vacante

Theradex Oncology in the United Kingdom seeks a Senior Medical Writer (Permanent, Full‑time) with 5+ years in a CRO/pharmaceutical setting to join our team. You will contribute across the full regulatory medical writing lifecycle, crafting high‑quality documents and engaging with sponsors and cross‑functional teams.

You will collaborate with medical monitors and leadership, shape scientific narratives, and mentor junior writers in a dynamic environment that values accuracy and timely delivery.

Formación

• Bachelor’s degree required; advanced degree preferred.
• 5+ years CRO/pharmaceutical environment experience.
• 3+ years regulatory medical writing experience in oncology.
• Lead writer on 3+ of: protocols, CSRs, brochures, DSURs, INDs.
• Experience collaborating with clients/sponsors and review timelines.
• Proven experience with Fast Track INDs/BTDRs.
• Familiarity with eCTD modules.
• Knowledge of US/international regulatory guidelines in oncology.
• Ability to work independently, meet deadlines, and be results-oriented.
• Excellent MS Office skills and attention to detail.

Responsabilidades

• Regulatory submissions preparation: INDs and amendments.
• Prepare Clinical Study Protocols and amendments.
• Prepare Investigator Brochures and updates.
• Prepare interim and final CSRs and IND Annual Reports.
• Prepare DSURs and Patient Informed Consent Forms.
• Provide cross-functional guidance and mentorship to in-house teams.

Conocimientos

Regulatory medical writing

Client facing

Cross-functional collaboration

Team mentorship

Regulatory strategy

Educación

Bachelor's degree

Advanced degree preferred

Herramientas

eCTD modules

MS Office Suite

Descripción del empleo

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 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

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

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.