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- Tasks: Research and write regulatory documents while mentoring junior writers.
- Company: Join MMS Holdings, a top-rated CRO known for innovation in drug development.
- Benefits: Enjoy a fully remote role with flexible working options and a supportive team culture.
- Why this job: Lead impactful projects in a collaborative, science-driven environment with a focus on excellence.
- Qualifications: Bachelor’s degree required; 6+ years in regulatory writing preferred, with strong scientific skills.
- Other info: Opportunity to work with global clients and contribute to significant medical advancements.
The predicted salary is between 36000 - 60000 £ per year.
MMS Holdings is an award-winning, data-focused Contract Research Organization (CRO) that partners with pharmaceutical, biotech, and medical device industries to deliver scientifically robust regulatory submissions and clinical trial solutions. With a global presence and a 97% customer satisfaction rate, MMS combines deep industry expertise with advanced technology to meet stringent regulatory requirements. Recognized as a top CRO for three consecutive years, MMS is dedicated to innovation and excellence in drug development.
Key Responsibilities:
- Research, analyze, and interpret medical literature to ensure scientific accuracy and regulatory compliance in clinical documents.
- Author and edit high-quality regulatory documents, including clinical protocols, study reports, investigator brochures, informed consent forms, and Module 2 (2.5, 2.7.1-2.7.4) submissions.
- Manage multiple writing assignments, adhering to deadlines while maintaining consistency with client templates and style guides.
- Serve as a primary point of contact for clients, coordinating project requirements and ensuring clear communication.
- Mentor junior writers and contribute to process improvements in document development.
- Lead cross-functional teams in preparing complex regulatory submissions under tight timelines.
Requirements:
- Education: Bachelor’s degree (Master’s or PhD preferred) in life sciences, medicine, or a related field.
- Experience: Minimum 6+ years in regulatory medical writing, with substantial expertise in clinical study protocols and reports.
- Skills: Exceptional scientific writing and editing abilities.
- Proficiency in MS Word, Excel, PowerPoint, and document management tools.
- Strong project leadership and team collaboration skills.
- In-depth knowledge of ICH guidelines, GCP, and FDA/EMA regulations.
- Preferred: Experience with orphan drug designations, PSP/PIPs, or regulatory submissions (e.g., CSR, IB).
Why Apply?
- Fully remote role with a globally recognized CRO.
- Opportunity to lead high-impact regulatory documents and mentor teams.
- Collaborative, science-driven work environment.
Apply Now: Submit Your Application Here
Contact Detail:
Workinvirtual Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer (Regulatory) – Remote MMS The Difference is in the Data
✨Tip Number 1
Familiarise yourself with the latest ICH guidelines and FDA/EMA regulations. 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 community. Engaging with others in the field can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss specific examples of your past work, especially those that highlight your experience with clinical study protocols and regulatory submissions. Real-life scenarios can showcase your expertise effectively.
✨Tip Number 4
Demonstrate your leadership skills by discussing any mentoring or team collaboration experiences you've had. Highlighting these abilities can set you apart as a candidate who can contribute to process improvements.
We think you need these skills to ace Senior Medical Writer (Regulatory) – Remote MMS The Difference is in the Data
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of the Senior Medical Writer position. Familiarise yourself with the types of documents you will be expected to author and edit, as well as the regulatory guidelines relevant to the role.
Tailor Your CV: Craft your CV to highlight your experience in regulatory medical writing, particularly focusing on your expertise in clinical study protocols and reports. Be sure to include specific examples of your work that demonstrate your scientific writing and editing abilities.
Write a Compelling Cover Letter: Your cover letter should not only express your interest in the position but also showcase your understanding of MMS Holdings and its commitment to innovation in drug development. Mention how your skills align with their needs and how you can contribute to their success.
Proofread Your Application: Before submitting your application, take the time to proofread all your documents. Ensure there are no grammatical errors or typos, as attention to detail is crucial in regulatory writing. A polished application reflects your professionalism and commitment to quality.
How to prepare for a job interview at Workinvirtual
✨Showcase Your Writing Skills
As a Senior Medical Writer, your writing abilities are crucial. Bring samples of your previous work to the interview, especially regulatory documents like clinical protocols or study reports. This will demonstrate your expertise and attention to detail.
✨Understand Regulatory Guidelines
Familiarise yourself with ICH guidelines, GCP, and FDA/EMA regulations before the interview. Being able to discuss these topics confidently will show that you have the necessary knowledge to excel in the role.
✨Prepare for Project Management Questions
Expect questions about managing multiple writing assignments and meeting deadlines. Be ready to share specific examples from your past experiences where you successfully led projects or mentored junior writers.
✨Demonstrate Communication Skills
Since you'll be a primary point of contact for clients, it's essential to showcase your communication skills. Prepare to discuss how you've coordinated project requirements and ensured clear communication in previous roles.
