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For Companies At a Glance
- Tasks: Prepare regulatory and clinical documents for oncology trials.
- Company: Join a leading CRO focused on transforming cancer treatment since 1982.
- Benefits: Enjoy competitive pay, a supportive culture, and opportunities for growth.
- Why this job: Be part of groundbreaking research that impacts patients worldwide in a collaborative team.
- 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.
Locations
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. Being knowledgeable about current practices will not only boost your confidence but also demonstrate your commitment to staying updated in this fast-evolving field.
✨Tip Number 3
Prepare to discuss your experience with specific regulatory documents during interviews. Be ready to share examples of your work on IND applications, clinical study protocols, or any other relevant documents, highlighting your contributions and the impact they had on projects.
✨Tip Number 4
Showcase your teamwork and mentoring skills. Since the role involves guiding junior writers, be prepared to discuss how you've supported colleagues in the past, whether through training, feedback, or collaboration on projects.
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. 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 role, as this will demonstrate your expertise and passion for the field.
✨Prepare for Regulatory Writing Questions
Since the role involves regulatory medical writing, brush up on your knowledge of IND applications, clinical study protocols, and other relevant documents. Expect questions about your experience with these documents and be ready to provide examples of your work.
✨Emphasise Collaboration Skills
This position requires strong teamwork abilities. Be ready to share examples of how you've successfully collaborated with clients or internal teams in the past, especially in managing document timelines and coordinating review meetings.
✨Demonstrate Your Mentorship Experience
As a Senior Medical Writer, you'll be expected to mentor junior writers. Prepare to discuss any previous mentoring experiences you have, including how you supported their development and contributed to their success.
