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- Tasks: Write and edit clinical documents, ensuring scientific accuracy and regulatory compliance.
- Company: Join an award-winning CRO known for its supportive and innovative culture.
- Benefits: Enjoy remote work, competitive salary, and a focus on career growth.
- Why this job: Make a real impact in clinical research while working with a collaborative team.
- Qualifications: 6+ years of regulatory writing experience and strong leadership skills required.
- Other info: Be part of a globally recognised organisation with excellent employee retention.
The predicted salary is between 36000 - 60000 £ per year.
Are you looking to join a company where your contributions truly matter, and where you\’ll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn.
We are looking for a full-time employee, remotely based within the UK.
Responsibilities
Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
Write and edit clinical development documents, including but not limited to, clinical protocols, investigator\’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
Complete writing assignments in a timely manner
Maintain timelines and workflow of writing assignments
Practice good internal and external customer service
Highly proficient with styles of writing for various regulatory documents
Expert proficiency with client templates & style guides
Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
Contribute substantially to, or manages, production of interpretive guides
Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
Mentor medical writers and other members of the project team who are involved in the writing process
Requirements
Bachelor\’s, Masters or PhD Degree in scientific, medical, clinical discipline or related field is required with at least 6 years of previous regulatory writing experience; Masters or Phd degree is preferred
Substantial clinical study protocol experience, as lead author, required
Experience leading and managing teams while authoring regulatory documents with aggressive timelines
Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
Understanding of clinical data
Exceptional writing skills are a must
Excellent organizational skills and the ability to multi-task are essential prerequisites
Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
Experience being a project lead, or managing a project team
Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
Substantial clinical study protocol experience, as lead author, required
Experience leading and managing teams while authoring regulatory documents with aggressive timelines
Not required, but experience with orphan drug designations and PSP/PIPs a plus
Principal Medical Writer employer: MMS
Contact Detail:
MMS Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Medical Writer
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. At MMS, they value collaboration and innovation, so think about how your skills align with their mission. We suggest practising common interview questions and having a few of your own ready to show your interest.
✨Tip Number 3
Showcase your expertise! Bring along samples of your previous work or case studies that highlight your writing skills and regulatory experience. This will give potential employers a taste of what you can bring to the table, especially in a role as crucial as a Principal Medical Writer.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive and engaged with our hiring process.
We think you need these skills to ace Principal Medical Writer
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Principal Medical Writer role. Highlight your relevant experience in regulatory writing and clinical study protocols, as this will show us you’re a perfect fit for our team.
Showcase Your Skills: Don’t just list your qualifications; demonstrate your exceptional writing skills and organisational abilities. Use specific examples from your past work to illustrate how you've successfully managed projects and met tight deadlines.
Be Authentic: Let your personality shine through in your application. We value a collaborative and inclusive environment, so showing us who you are and how you can contribute to our culture is key!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates about your application status.
How to prepare for a job interview at MMS
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical research and regulatory writing. Familiarise yourself with the specific documents mentioned in the job description, like clinical protocols and study reports. This will show that you're not just a good writer, but also understand the science behind it.
✨Showcase Your Experience
Prepare to discuss your previous experience in regulatory writing and managing teams. Have specific examples ready that highlight your leadership skills and how you've successfully met tight deadlines. This will demonstrate your capability to handle the responsibilities of the role.
✨Be Ready to Collaborate
Since the role involves interacting with clients and team members, be prepared to discuss how you approach collaboration. Share examples of how you've worked with others to achieve project goals, as this aligns with MMS's emphasis on a supportive and inclusive work environment.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the team dynamics, ongoing projects, or how MMS supports professional development. This shows your genuine interest in the company and helps you gauge if it's the right fit for you.