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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 a collaborative culture.
- Why this job: Make a real impact in healthcare while developing your writing skills.
- Qualifications: 2+ years in medical writing, especially regulatory; Master's degree preferred.
- Other info: Work remotely with occasional office visits in Surrey; team days once a month.
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.
Qualifications:
- 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.
Additional Skills:
- 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: JR United Kingdom
Contact Detail:
JR United Kingdom 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 through platforms like LinkedIn. Engaging with industry groups can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your previous work in regulatory writing during interviews. Highlighting your experience with key documents like Investigator Brochures and Clinical Study Reports will set you apart.
✨Tip Number 4
Showcase 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 resonate well with potential employers.
We think you need these skills to ace Regulatory Medical Writer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory writing and medical documentation. Focus on specific projects you've worked on, especially those related to clinical trials and submissions.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for medical writing and regulatory affairs. Mention your understanding of ICH, FDA, and EMA guidelines, and how your skills align with the company's values of innovation and collaboration.
Highlight Relevant Experience: In your application, emphasise your minimum of 2 years’ experience in medical writing. Provide examples of key regulatory documents you have developed, such as Investigator Brochures or Clinical Study Reports.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Ensure there are no grammatical errors and that all information is clear and precise, reflecting your attention to detail.
How to prepare for a job interview at JR United Kingdom
✨Know Your Regulatory Guidelines
Familiarise yourself with ICH, FDA, and EMA guidelines before the interview. Being able to discuss these regulations confidently will demonstrate your expertise and understanding of the regulatory landscape.
✨Showcase Your Writing Skills
Prepare samples of your previous regulatory documents, such as Investigator Brochures or Clinical Study Reports. Highlighting your writing style and attention to detail can set you apart from other candidates.
✨Emphasise Collaboration Experience
Be ready to discuss your experience working with cross-functional teams. Share specific examples of how you collaborated with clinical and regulatory teams to meet deadlines and ensure compliance.
✨Demonstrate Problem-Solving Abilities
Think of instances where you faced challenges in your writing projects and how you overcame them. Showing your proactive attitude and creative problem-solving skills will resonate well with the interviewers.
