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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 opportunities for growth.
- Why this job: Be part of groundbreaking cancer research in a collaborative environment.
- Qualifications: 5+ years in medical writing, with oncology experience preferred.
- Other info: Mentorship opportunities available for junior writers.
The predicted salary is between 43200 - 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
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. Keeping up-to-date with changes in regulations can give you an edge during interviews, as it shows 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 relate to the responsibilities of a Senior Medical Writer. Be ready to share examples of your lead writing experience and how you managed timelines and collaborated with teams, as this will demonstrate your suitability for the role.
✨Tip Number 4
Showcase your understanding of drug safety principles and clinical trial methodology during interviews. Being able to articulate these concepts clearly will highlight your expertise and reassure the hiring team that you can handle the complexities of regulatory medical writing in oncology.
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 roles 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 and your understanding of the complexities involved in clinical trials. Mention your collaborative skills and how you can contribute to the team.
Highlight Relevant Experience: In your application, clearly outline your 5+ years of experience in a CRO or pharmaceutical environment. Detail your familiarity with eCTD modules and your ability to manage multiple projects simultaneously.
Showcase Communication Skills: Since excellent communication is key for this role, provide examples of how you've effectively communicated with clients or sponsors in previous positions. This could include coordinating review meetings or preparing document timelines.
How to prepare for a job interview at Life Sciences Recruitment
✨Showcase Your Experience
Be prepared to discuss your previous roles in detail, especially your experience with regulatory medical writing. Highlight specific projects you've worked on, particularly those related to oncology, and explain your contributions.
✨Understand the Company’s Focus
Research the company’s history and its ongoing collaborations, especially with the National Cancer Institute. Demonstrating knowledge about their work in oncology will show your genuine interest in the role and the organisation.
✨Prepare for Technical Questions
Expect questions related to drug safety principles, clinical trial methodology, and regulatory guidelines. Brush up on these topics and be ready to discuss how you’ve applied this knowledge in your past roles.
✨Emphasise Team Collaboration
Since the role requires strong teamwork, be ready to share examples of how you've successfully collaborated with others in your previous positions. Discuss any mentoring experiences you have had with junior writers as well.
