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 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
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 excellent employer, offering a supportive and collaborative work culture that values employee growth and development. With a competitive compensation package and benefits such as a 6% pension contribution and private medical insurance, employees can thrive both professionally and personally in the vibrant Crawley area, conveniently located near Gatwick Airport.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Medical Writer
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Theradex Oncology. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Theradex Oncology.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Theradex Oncology. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Theradex Oncology is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Medical Writer
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Theradex Oncology!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Theradex Oncology that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Theradex Oncology!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Theradex Oncology, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Theradex Oncology
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Theradex Oncology that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Theradex Oncology’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
