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- Tasks: Lead the creation of essential clinical regulatory documents and manage project timelines.
- Company: Join a dynamic team at Trilogy, dedicated to impactful medical writing.
- Benefits: Enjoy competitive pay, flexible work options, and opportunities for professional growth.
- Why this job: Make a difference in healthcare while collaborating with diverse teams and clients.
- Qualifications: 3+ years of regulatory writing experience and a relevant degree required.
- Other info: Fluency in English and strong interpersonal skills are a must!
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
As a Senior Medical Writer, you will be responsible for 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
- Experience working directly with clients or sponsors, including document timeline preparation, review cycles, and coordination of review meetings
- Familiarity with eCTD modules
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
Make sure to highlight your experience with regulatory documents in your conversations. When networking or during interviews, discuss specific projects where you were the lead writer and how you managed timelines and budgets.
✨Tip Number 2
Familiarize yourself with the document management systems commonly used in the industry. If you have experience with specific tools, be ready to discuss how you've utilized them to streamline your writing process.
✨Tip Number 3
Demonstrate your interpersonal skills by preparing examples of how you've successfully collaborated with clients and team members. Be ready to share instances where you coordinated review cycles or facilitated meetings effectively.
✨Tip Number 4
Stay updated on the latest trends and regulations in medical writing. Being knowledgeable about current practices will not only help you in interviews but also show your commitment to the field.
We think you need these skills to ace Senior Medical Writer
Some tips for your application 🫡
Highlight Relevant Experience: Make sure to emphasize your experience in writing clinical regulatory documents. Clearly outline your role as a lead writer on the required documents, such as Clinical Study Protocols and Clinical Study Reports, to demonstrate your qualifications.
Showcase Project Management Skills: Detail your project management experience, including how you have managed timelines and budgets for document preparation. Mention any specific tools or systems you have used to coordinate review cycles and client interactions.
Demonstrate Attention to Detail: Since the role requires an appreciation for well-written documents, provide examples of how your attention to detail has positively impacted your previous work. This could include instances where your thoroughness improved document quality or compliance.
Tailor Your Application: Customize your CV and cover letter to align with the job description. Use keywords from the job posting to ensure your application resonates with the hiring team and highlights your fit for the Senior Medical Writer position.
How to prepare for a job interview at Life Sciences Recruitment
✨Showcase Your Writing Experience
Be prepared to discuss your specific experiences as a lead writer on clinical regulatory documents. Highlight at least three key projects where you played a significant role, detailing the types of documents you produced and the impact they had.
✨Demonstrate Project Management Skills
Since project management is crucial for this role, come ready to share examples of how you've managed timelines and coordinated review cycles in past projects. Discuss any tools or systems you used to keep everything on track.
✨Highlight Client Interaction Experience
Prepare to talk about your experience interacting with clients or authors. Share specific instances where you successfully coordinated meetings or navigated feedback, showcasing your interpersonal skills and ability to work with diverse teams.
✨Emphasize Attention to Detail
Given the importance of detail in medical writing, be ready to discuss how you ensure accuracy and quality in your documents. You might want to mention any specific strategies or checklists you use to maintain high standards.
