Senior Medical Writer (Oncology)

Celebrating 40+ Years!

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.

The Senior Medical Writer will be part of the growing team within Theradex and have a client facing, collaborative role with direct involvement with medical monitors and senior leadership.

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 experience preferred)
• Lead writer experience 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.