At a Glance
- 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 flexibility, competitive salary, and a focus on career growth.
- Other info: Be part of a dynamic environment with opportunities to mentor and lead.
- Why this job: Make a real impact in clinical research while working with a collaborative team.
- Qualifications: 6+ years of regulatory writing experience; advanced degree preferred.
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 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.
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.
Principal Medical Writer (Remote - UK) in London employer: MMS
At MMS, we are committed to creating a workplace where your expertise as a Senior Statistical Programmer is valued and nurtured. Our Great Place to Work certification reflects our dedication to fostering a supportive and innovative culture, offering exceptional employee retention rates and opportunities for professional growth. Join us in our remote UK team and be part of a collaborative environment that not only prioritises your career advancement but also shapes the future of clinical research.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Medical Writer (Remote - UK) in London
✨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 on job openings.
✨Tip Number 2
Prepare for interviews by practising common questions related to medical writing and regulatory submissions. We recommend doing mock interviews with friends or using online platforms to boost your confidence.
✨Tip Number 3
Showcase your expertise! Create a portfolio of your best writing samples, especially those that highlight your experience with clinical documents. This will help you stand out during interviews.
✨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 our innovative team at MMS.
We think you need these skills to ace Principal Medical Writer (Remote - UK) in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the Principal Medical Writer role. Highlight your regulatory writing experience and any relevant clinical study protocol work to catch our eye!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Share why you're passionate about clinical research and how your background makes you a perfect fit for our team at MMS. Keep it engaging and personal!
Showcase Your Writing Skills:As a Medical Writer, your writing skills are crucial. Include samples of your previous work or describe projects where you’ve demonstrated your ability to write clear and concise regulatory documents.
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’re considered for this exciting opportunity with MMS!
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 interested in the role but also understand the nuances of the work.
✨Showcase Your Experience
Prepare to discuss your previous regulatory writing experience in detail. Be ready to share examples of how you've led projects or mentored others. Highlight any specific challenges you faced and how you overcame them, especially under tight deadlines.
✨Communicate Clearly
Since the role involves direct communication with clients, practice articulating your thoughts clearly and concisely. You might even want to do a mock interview with a friend to refine your communication skills. Remember, clarity is key in both writing and speaking!
✨Ask Insightful Questions
Prepare some thoughtful questions about the company culture and team dynamics at MMS. This shows that you're genuinely interested in being part of their supportive and innovative environment. Plus, it gives you a chance to assess if it's the right fit for you too!
