At a Glance
- Tasks: Join us as a Senior Medical Writer, crafting vital documents for cancer research.
- Company: Theradex Oncology has over 40 years of experience in oncology trials worldwide.
- Benefits: Enjoy remote work options and a competitive compensation package tailored to your location.
- Other info: This role is remote across several European countries; no company sponsorship available.
- Why this job: Be part of groundbreaking cancer therapies and work in a supportive, people-first culture.
- Qualifications: 5+ years in medical writing, preferably in oncology, with strong communication skills required.
The predicted salary is between 43200 - 72000 £ per year.
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.
Senior Medical Writer employer: Theradex Oncology
Theradex Oncology is an exceptional employer, offering a collaborative and supportive work culture that prioritises the well-being of its employees. With over 40 years of experience in oncology trials, we provide meaningful opportunities for professional growth and development, particularly for those passionate about making a difference in cancer treatment. Our remote positions across the UK, Italy, Sweden, France, and Spain allow for flexibility while being part of a mission-driven team dedicated to improving patient outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Medical Writer
✨Tip Number 1
Familiarise yourself with the specific oncology trials that Theradex has conducted. Understanding their past projects will not only help you in interviews but also show your genuine interest in their work.
✨Tip Number 2
Network with current or former employees of Theradex on platforms like LinkedIn. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during the interview process.
✨Tip Number 3
Prepare to discuss your experience with regulatory medical writing in detail. Be ready to share specific examples of documents you've authored, particularly those related to IND applications and clinical study protocols.
✨Tip Number 4
Stay updated on the latest trends and regulations in oncology and medical writing. This knowledge will not only enhance your confidence but also demonstrate your commitment to staying at the forefront of the industry.
We think you need these skills to ace Senior Medical Writer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your relevant experience in regulatory medical writing, especially in oncology. Include specific examples of documents you've authored, such as Clinical Study Protocols or IND applications.
Craft a Compelling Cover Letter:Write a cover letter that showcases your passion for oncology and your understanding of the regulatory writing process. Mention your collaborative skills and how you can contribute to Theradex's mission.
Highlight Relevant Experience:In your application, emphasise your 5+ years of experience in a CRO or pharmaceutical environment. Detail your lead writer experience on key documents and your familiarity with eCTD modules.
Proofread Your Application:Before submitting, thoroughly proofread your application materials. Ensure there are no grammatical errors and that your writing is clear and concise, reflecting the strong communication skills required for the role.
How to prepare for a job interview at Theradex Oncology
✨Showcase Your Experience
Make sure to highlight your 5+ years of experience in a CRO or pharmaceutical environment. Be prepared to discuss specific projects you've worked on, especially those related to regulatory medical writing in oncology.
✨Understand the Role
Familiarise yourself with the key responsibilities of a Senior Medical Writer at Theradex. Be ready to talk about your experience with IND applications, clinical study protocols, and other relevant documents.
✨Demonstrate Collaboration Skills
Since the role requires collaboration with various teams, prepare examples that showcase your ability to work effectively with others. Discuss how you've supported in-house units or guided new medical writers in the past.
✨Know the Regulatory Landscape
Brush up on your knowledge of EU, US, and international regulatory guidelines. Being able to discuss these principles confidently will show that you are well-prepared for the challenges of the role.
