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- Tasks: Create and manage regulatory documents for pharmaceuticals and medical devices.
- Company: Join a dynamic team focused on innovation and improving patient outcomes.
- Benefits: Flexible work options with corporate perks and team-building events.
- Why this job: Be part of a collaborative culture that values creativity and impactful work.
- Qualifications: 2+ years in medical writing, especially regulatory; Master's degree preferred.
- Other info: Work remotely with occasional office visits in Surrey; monthly team days.
The predicted salary is between 36000 - 60000 £ per year.
We are seeking a motivated and experienced Regulatory Medical Writer to join our clients dynamic team. The company values innovation, creativity, and collaboration to improve patient outcomes.
As a Regulatory Medical Writer, you will be responsible for creating and managing high-quality regulatory documents to support the development of pharmaceuticals and medical devices. The ideal candidate will have a solid background in regulatory writing with a focus on clinical trials and submissions. You will collaborate with various internal teams to ensure compliance with regulatory requirements and contribute to the successful development of new treatments.
Key Responsibilities:- Develop and write key regulatory documents, including but not limited to Investigator Brochures, Protocols, ILAP applications, CTD submissions, IMPD/INDs, DSURs, Clinical Study Reports, TDPs, and NDAs.
- Ensure the accuracy, clarity, and compliance of all documents with regulatory guidelines and company standards.
- Collaborate closely with clinical, regulatory, and project teams to gather required information and ensure the timely delivery of documentation.
- Contribute to document review and approval processes, ensuring high-quality output and adherence to timelines.
- Actively participate in team meetings, offering solutions and insights to improve processes and outcomes.
- A minimum of 2 years’ experience in medical writing, particularly within regulatory writing.
- Proficient in writing clinical trial-related documents, including Investigator Brochures, Protocols, IMPDs/INDs, DSURs, and Clinical Study Reports.
- Strong understanding of regulatory requirements, including ICH, FDA, and EMA guidelines.
- Master’s degree in life sciences (PhD preferred).
- Excellent written and verbal communication skills, with an eye for detail and precision.
- Creative problem-solving skills with a proactive attitude.
- Ability to work independently and manage multiple tasks in a fast-paced environment.
- Collaborative mindset with strong interpersonal skills to interact with various teams.
- Ability to work under pressure and meet tight deadlines.
This position can be based anywhere in the UK. The candidate will be expected to attend the office in Surrey, as required, and participate in at least one team day per month.
If you are passionate about medical writing and regulatory affairs, and you're looking for a dynamic and rewarding career opportunity, we encourage you to apply.
Regulatory Medical Writer employer: Barrington James
Contact Detail:
Barrington James Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Medical Writer
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines from ICH, FDA, and EMA. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory writing field. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory writing.
✨Tip Number 3
Prepare to discuss specific examples of your previous work in regulatory writing during interviews. Highlight your experience with key documents like Investigator Brochures and Clinical Study Reports to showcase your expertise.
✨Tip Number 4
Demonstrate your collaborative skills by preparing to discuss how you've worked with cross-functional teams in the past. Emphasising your ability to gather information and meet deadlines will make you a strong candidate for this role.
We think you need these skills to ace Regulatory Medical Writer
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Regulatory Medical Writer. Familiarise yourself with the types of documents you'll be expected to write and the regulatory guidelines that govern them.
Tailor Your CV: Highlight your relevant experience in medical writing, particularly focusing on regulatory documents. Be specific about your past roles and how they relate to the job description provided by the company.
Craft a Compelling Cover Letter: Use your cover letter to showcase your passion for medical writing and regulatory affairs. Mention specific experiences that demonstrate your skills in writing clinical trial-related documents and your understanding of regulatory requirements.
Proofread Your Application: Ensure that your application is free from errors. Given the importance of clarity and precision in regulatory writing, a well-proofread application will reflect your attention to detail and professionalism.
How to prepare for a job interview at Barrington James
✨Showcase Your Regulatory Knowledge
Make sure to brush up on the latest ICH, FDA, and EMA guidelines before your interview. Being able to discuss these regulations confidently will demonstrate your expertise and understanding of the role.
✨Prepare Examples of Your Work
Have specific examples ready that highlight your experience in writing regulatory documents like Investigator Brochures or Clinical Study Reports. This will help you illustrate your skills and how they align with the job requirements.
✨Emphasise Collaboration Skills
Since the role involves working closely with various teams, be prepared to discuss your collaborative experiences. Share instances where you successfully worked with clinical or regulatory teams to achieve a common goal.
✨Demonstrate Problem-Solving Abilities
Think of situations where you faced challenges in your previous roles and how you overcame them. Highlighting your creative problem-solving skills will show that you can contribute positively to the team.
