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For Companies At a Glance
- Tasks: Lead medical writing projects and create essential clinical documents.
- Company: Join a top biopharmaceutical firm dedicated to innovative healthcare solutions.
- Benefits: Enjoy competitive pay, flexible work options, and professional growth opportunities.
- Why this job: Make a real impact in healthcare while collaborating with experts in the field.
- Qualifications: Requires a Bachelor’s degree and 5+ years in biotechnology writing.
- 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.
✨Tip Number 3
Showcase your experience with various types of clinical 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 IND submissions or clinical study reports.
✨Tip Number 4
Brush up on your presentation skills. As you'll be representing the Medical Writing department at meetings and conferences, being able to clearly communicate complex information will set you apart from other candidates.
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 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 Your Application: Before submitting, thoroughly proofread your application materials. Ensure there are no grammatical errors and that your writing style aligns with the AMA style guide, as this is crucial for a role focused on medical writing.
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, such as clinical study protocols or reports, to demonstrate your expertise and familiarity with the required documentation.
✨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 industry's requirements.
✨Discuss Your Project Management Experience
Highlight your experience managing multiple projects within budget and time constraints. Share specific examples of how you've communicated changes to leadership and ensured that all deliverables were met on time.
✨Prepare for Technical Questions
Expect technical questions related to clinical research principles and data interpretation. Brush up on your knowledge of statistical analysis plans and be ready to explain how you review and ensure the accuracy of content in medical writing.
