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- Tasks: Lead medical writing for clinical studies and regulatory submissions.
- Company: Join a top biopharmaceutical firm focused on innovative solutions.
- Benefits: Enjoy a collaborative environment with opportunities for professional growth.
- Why this job: Make a real impact in healthcare by translating complex data into actionable insights.
- Qualifications: 5+ years in biotech, strong writing skills, and knowledge of FDA regulations required.
- Other info: Ideal for those passionate about clinical research and regulatory affairs.
The predicted salary is between 43200 - 72000 £ per year.
Principal Medical Writer 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: 1. Clinical study protocols and clinical protocol amendments; 2. Clinical study reports; 3. Patient narratives; 4. Clinical development plans; 5. IND submissions and annual reports; 6. Integrated summary reports; 7. NDA and (e)CTD submissions; 8. Investigator brochures, as well as; 9. Clinical journal manuscripts, clinical journal abstracts, and client presentations. * Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. * Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates when completing medical writing projects, on-time and on-budget. * Understands budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. 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 Regulatory 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 Regulatory Medical Writer
✨Tip Number 1
Make sure to showcase your extensive experience in biotechnology during networking events or conferences. Engage with professionals in the field and discuss your past projects, as this can help you stand out as a candidate.
✨Tip Number 2
Familiarize yourself with the latest ICH-E3 guidelines and FDA regulations. Being able to discuss these topics confidently in interviews will demonstrate your expertise and commitment to regulatory standards.
✨Tip Number 3
Join relevant online forums or groups focused on medical writing and biotechnology. Engaging in discussions can help you learn about industry trends and may even lead to job referrals.
✨Tip Number 4
Consider reaching out to current or former employees of the company for informational interviews. This can provide you with insider knowledge about the company culture and expectations, which can be invaluable during the interview process.
We think you need these skills to ace Principal Regulatory Medical Writer
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities of a Principal Regulatory Medical Writer. Familiarize yourself with the types of documents you'll be expected to produce and the regulatory standards that apply.
Tailor Your CV: Highlight your relevant experience in biotechnology and medical writing. Emphasize your familiarity with ICH guidelines and your ability to develop clinical documents. Use specific examples to demonstrate your expertise.
Craft a Strong Cover Letter: In your cover letter, express your passion for medical writing and how your background aligns with the company's mission. Mention your experience with various therapeutic areas and your understanding of FDA regulations.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for grammar and formatting errors. Ensure that your application reflects the high standards expected in regulatory writing.
How to prepare for a job interview at Key Life Sciences
✨Showcase Your Experience
Be prepared to discuss your extensive experience in biotechnology and the various therapeutic areas you've worked in. Highlight specific projects where you represented the Medical Writing department and how you contributed to clinical study teams.
✨Familiarize Yourself with Regulatory Standards
Make sure you understand ICH-E3 guidelines and other regulatory standards relevant to medical writing. Be ready to explain how you have adhered to these standards in your previous work, especially in relation to IND submissions and NDA processes.
✨Demonstrate Your Writing Skills
Bring samples of your writing that showcase your ability to develop clinical study protocols, reports, and other documents. Be prepared to discuss your familiarity with the AMA style guide and how you ensure grammatical accuracy and consistency in your work.
✨Discuss Budget Management
Since understanding budget specifications is crucial for this role, be ready to talk about how you've managed project budgets in the past. Share examples of how you communicated changes to leadership and ensured projects were completed on-time and within budget.
