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For Companies At a Glance
- Tasks: Evaluate and write 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 flexibility, competitive salary, and a focus on career growth.
- Why this job: Make a real impact in the pharmaceutical industry while working with a collaborative team.
- Qualifications: 6+ years of regulatory writing experience and a degree in a relevant field.
- Other info: Great opportunity for mentorship and leadership in a dynamic environment.
The predicted salary is between 36000 - 60000 £ per year.
Overview
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 an 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 www.mmsholdings.com 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
- Not required, but experience with orphan drug designations and PSP/PIPs a plus
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Principal Medical Writer (Remote - UK) employer: MMS
Contact Detail:
MMS Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Medical Writer (Remote - UK)
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at MMS or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to medical writing. We recommend role-playing with a friend or using online resources to get comfortable discussing your experience and skills.
✨Tip Number 3
Showcase your expertise! Bring along samples of your previous work or case studies that highlight your writing skills and regulatory knowledge. This will demonstrate your capability and give interviewers a taste of what you can bring to the team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining MMS and being part of our innovative team.
We think you need these skills to ace Principal Medical Writer (Remote - UK)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Principal Medical Writer role. Highlight your relevant experience in regulatory writing and clinical study protocols, as this will show us you’re a great fit for the position.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about medical writing and how your skills align with our mission at MMS. Keep it concise but impactful!
Showcase Your Writing Skills: Since writing is key for this role, consider including samples of your previous work or projects. This gives us a taste of your style and expertise, so we can see what you bring to the table.
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 from our team!
How to prepare for a job interview at MMS
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical study protocols and regulatory writing. Familiarise yourself with the specific documents mentioned in the job description, like clinical study reports and investigator’s brochures. This will show that you're not just a good writer, but also someone who understands the nuances of the medical field.
✨Showcase Your Experience
Prepare to discuss your previous regulatory writing experience in detail. Be ready to share examples of how you've led teams or managed projects under tight deadlines. Highlight any specific challenges you faced and how you overcame them, as this will demonstrate your problem-solving skills and leadership abilities.
✨Be Organised
Since the role requires excellent organisational skills, come prepared with a clear structure for your answers during the interview. Use the STAR method (Situation, Task, Action, Result) to articulate your experiences. This will help you stay focused and ensure you cover all the important points without rambling.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company and the role. Inquire about their approach to mentoring medical writers or how they foster collaboration within teams. This not only shows your enthusiasm but also helps you gauge if the company culture aligns with your values.
