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- Tasks: Lead medical writing projects, develop clinical documents, and ensure regulatory compliance.
- Company: Join a top biopharmaceutical firm dedicated to accelerating customer success through innovative solutions.
- Benefits: Enjoy competitive pay, flexible work options, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while collaborating with experts in a dynamic environment.
- Qualifications: Bachelor's degree required; 5+ years in biotechnology and strong writing skills essential.
- Other info: Ideal for those passionate about clinical research and regulatory standards.
The predicted salary is between 48000 - 72000 £ per year.
My client is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. They are looking for a Principal Regulatory Writer, with extensive experience in biotechnology, of at least 5 years, covering multiple therapeutic areas.
Job Responsibilities:
- Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.
- Develops or supports a variety of documents that include but not limited to:
- Clinical study protocols and clinical protocol amendments;
- Clinical study reports;
- Patient narratives;
- Clinical development plans;
- IND submissions and annual reports;
- Integrated summary reports;
- NDA and (e)CTD submissions;
- Investigator brochures;
- Clinical journal manuscripts, clinical journal abstracts, and client presentations.
Requirements and qualifications:
- Bachelor of Science degree with relevant writing experience.
- Extensive knowledge of English grammar with a familiarity with AMA style guide.
- Understanding of FDA and ICH regulations and guidelines.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Fluency with principles of clinical research and to interpret and present clinical data and other complex information.
Principal MEdical Writer employer: Key Life Sciences
Contact Detail:
Key Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal MEdical Writer
✨Tip Number 1
Network with professionals in the biopharmaceutical industry. Attend relevant conferences and seminars where you can meet potential colleagues or employers. Engaging in conversations about your expertise in medical writing can help you stand out.
✨Tip Number 2
Familiarise yourself with the latest ICH and FDA regulations. Being well-versed in these guidelines will not only boost your confidence but also demonstrate your commitment to compliance, which is crucial for a Principal Medical Writer role.
✨Tip Number 3
Showcase your experience with various types of medical documents. Be prepared to discuss specific projects you've worked on, especially those that align with the responsibilities listed in the job description, such as clinical study protocols and IND submissions.
✨Tip Number 4
Brush up on your presentation skills. As a Principal Medical Writer, you'll need to present complex information clearly. Practising how to convey your ideas effectively can make a significant difference during interviews.
We think you need these skills to ace Principal MEdical Writer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in biotechnology and medical writing. Focus on relevant roles and projects that demonstrate your ability to develop clinical documents, as outlined in the job description.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the responsibilities of the Principal Medical Writer role. Mention your familiarity with ICH-E3 guidelines and your experience with various clinical documents, showcasing how you can contribute to the company's success.
Showcase Your Knowledge: In your application, emphasise your understanding of FDA and ICH regulations. You might want to include examples of how you've adhered to these standards in past projects, demonstrating your attention to detail and regulatory compliance.
Proofread for Perfection: Before submitting your application, thoroughly proofread all documents for grammar, format, and consistency. Given the importance of clear communication in medical writing, ensure that your application reflects your strong command of English grammar and adherence to the AMA style guide.
How to prepare for a job interview at Key Life Sciences
✨Showcase Your Writing Skills
As a Principal Medical Writer, your writing skills are paramount. Bring samples of your previous work to the interview, especially documents like clinical study protocols or reports. This will demonstrate your ability to produce high-quality, regulatory-compliant documents.
✨Understand Regulatory Standards
Familiarise yourself with ICH-E3 guidelines and FDA regulations before the interview. Be prepared to discuss how you have adhered to these standards in your past projects, as this will show your understanding of the regulatory landscape.
✨Prepare for Technical Questions
Expect questions about your experience with various therapeutic areas and the types of documents you've worked on. Brush up on your knowledge of clinical research principles and be ready to explain complex data clearly and concisely.
✨Demonstrate Team Collaboration
Since the role involves representing the Medical Writing department on clinical study teams, be ready to share examples of how you've successfully collaborated with cross-functional teams. Highlight your communication skills and ability to work within budget constraints.
