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- Tasks: Prepare regulatory and clinical documents for oncology trials.
- Company: Join a leading CRO focused on transforming cancer treatment since 1982.
- Benefits: Enjoy a competitive salary, supportive culture, and flexible work options.
- Why this job: Be part of groundbreaking cancer research in a collaborative team environment.
- Qualifications: 5+ years in medical writing, with oncology experience preferred.
- Other info: Opportunity to mentor junior writers and lead critical projects.
The predicted salary is between 48000 - 72000 £ per year.
My client is a full-service CRO specializing in oncology, conducting early and late-phase clinical trials across the U.S., Europe, and Asia. Established in 1982 with the award of the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI), my client has maintained a strong and ongoing collaboration with NCI, forming the foundation of its operations. With a dedicated focus on cancer research, my client has an in-depth understanding of oncology science and the complexities of transitioning therapies from preclinical to clinical development. To date, they have designed and managed over 250 oncology trials, striving to ensure that new cancer treatments have the best opportunity to benefit patients worldwide. Their vision is to enhance cancer treatment and transform it into a manageable disease.
Role Overview:
My client is seeking a highly collaborative Senior Medical Writer with 5+ years of experience to join their team. This role is ideal for a self-starter who wants to be involved in the full regulatory medical writing lifecycle.
Key Responsibilities
- Preparing a range of regulatory and clinical documents, including:
- Initial Investigational New Drug (IND) applications and amendments
- Clinical study protocols and protocol amendments
- Investigator’s brochures and updates
- Interim and final clinical study reports
- IND annual reports
- Development Safety Update Reports (DSURs)
- Patient informed consent forms
- Providing guidance and support to internal teams on manuals, training guidelines, and related documents
- Acting as a mentor and resource for junior medical writers
Experience:
- Minimum 5 years of experience in a CRO or pharmaceutical environment
- At least 3 years of experience in regulatory medical writing (oncology experience preferred)
- Lead writer experience on at least three of the following:
- Clinical Study Protocols
- Clinical Study Reports
- Investigator’s Brochures
- Development Safety Update Reports
- IND Applications
- Informed Consent Forms
Key Skills & Competencies
- Strong understanding of drug safety principles, clinical trial methodology, biostatistics, pharmacology, and oncology
- Familiarity with EU, US, and international regulatory guidelines
- Excellent knowledge of company and sponsor-specific SOPs
- Ability to work independently, meet deadlines, and manage multiple projects simultaneously
- Strong teamwork, organization, and attention to detail
- Excellent communication and interpersonal skills
- Advanced proficiency in Microsoft Office Suite
What’s on Offer
My client fosters a friendly and supportive work culture that prioritizes people. They offer a competitive compensation and benefits package aligned with country-specific requirements. If you are an experienced medical writer looking to contribute to cutting-edge oncology research in a dynamic and collaborative environment, this role could be the perfect fit for you.
Senior Medical Writer employer: Life Sciences Recruitment
Contact Detail:
Life Sciences Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer
✨Tip Number 1
Network with professionals in the oncology field. Attend industry conferences, webinars, or local meetups to connect with people who work in clinical research organisations (CROs) or pharmaceutical companies. This can help you gain insights into the role and potentially get referrals.
✨Tip Number 2
Familiarise yourself with the latest regulatory guidelines and trends in oncology research. Staying updated on changes in regulations can give you an edge during interviews, showing your commitment to the field and your proactive approach to professional development.
✨Tip Number 3
Prepare to discuss specific projects you've worked on that align with the responsibilities of a Senior Medical Writer. Be ready to share examples of your experience with IND applications, clinical study protocols, and any leadership roles you've taken on in previous positions.
✨Tip Number 4
Demonstrate your collaborative skills by preparing examples of how you've successfully worked with cross-functional teams. Highlighting your ability to mentor junior writers and support internal teams will show that you're a team player, which is crucial for this role.
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. Emphasise your lead writer experience and any specific documents you've worked on that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for oncology research and your understanding of the complexities involved in clinical trials. Mention how your skills and experiences make you a perfect fit for the Senior Medical Writer role.
Highlight Key Skills: In your application, clearly outline your familiarity with regulatory guidelines and your ability to manage multiple projects. Use specific examples to demonstrate your strong communication and teamwork skills.
Proofread Your Application: Before submitting, thoroughly proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial for a Senior Medical Writer.
How to prepare for a job interview at Life Sciences Recruitment
✨Showcase Your Oncology Knowledge
Make sure to highlight your understanding of oncology science during the interview. Be prepared to discuss specific trials you've worked on and how they relate to the complexities of transitioning therapies from preclinical to clinical development.
✨Demonstrate Regulatory Writing Experience
Since the role requires extensive regulatory medical writing experience, come ready to talk about your past projects. Discuss your lead writer experience on clinical study protocols, IND applications, and other relevant documents to show you meet their requirements.
✨Emphasise Collaboration Skills
This position values teamwork, so be sure to share examples of how you've successfully collaborated with internal teams or clients in the past. Highlight any mentoring experiences you've had with junior writers to showcase your leadership abilities.
✨Prepare for Technical Questions
Expect questions related to drug safety principles, clinical trial methodology, and regulatory guidelines. Brush up on EU, US, and international regulations to demonstrate your familiarity and confidence in these areas.
