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.
- 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 organisational skills required.
- Other info: Be part of a dynamic environment with opportunities to mentor and lead.
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 aaward-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, remotelybased 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
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Principal Medical Writer (Remote - UK) Regulatory and MW - Medical Writing LONDON, ENGLAND, UNI[...] employer: MMS Holdings Inc
Contact Detail:
MMS Holdings Inc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Medical Writer (Remote - UK) Regulatory and MW - Medical Writing LONDON, ENGLAND, UNI[...]
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend virtual events, and engage with professionals on LinkedIn. 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. Understand their values and how they align with yours. We want you to shine, so practice common interview questions and think about how your experience as a Medical Writer fits into their mission.
✨Tip Number 3
Showcase your expertise! Bring samples of your writing or projects to the interview. We love seeing how you tackle complex regulatory documents and your approach to clinical study protocols. It’s a great way to demonstrate your skills in action.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who want to be part of our innovative team at MMS. Let’s make it happen!
We think you need these skills to ace Principal Medical Writer (Remote - UK) Regulatory and MW - Medical Writing LONDON, ENGLAND, UNI[...]
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. We want to see how your skills align with what we’re looking for!
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 you can contribute to our innovative team. Keep it concise but impactful – we love a good story!
Showcase Your Writing Skills: Since writing is at the core of this role, consider including samples of your previous work or projects. This gives us a taste of your style and expertise, so don’t hold back on showcasing your best pieces!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, you’ll get to explore more about our amazing culture while you’re there!
How to prepare for a job interview at MMS Holdings Inc
✨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. Being able to discuss these confidently will show that you're serious about the role.
✨Showcase Your Experience
Prepare to share specific examples from your past work that highlight your expertise in medical writing and project management. Think about times when you led a team or met tight deadlines, as these experiences will resonate well with the interviewers.
✨Ask Insightful Questions
Interviews are a two-way street! Prepare thoughtful questions about the company culture, team dynamics, and ongoing projects. This not only shows your interest but also helps you gauge if the company is the right fit for you.
✨Demonstrate Your Communication Skills
As a Medical Writer, clear communication is key. During the interview, focus on articulating your thoughts clearly and concisely. This will give the interviewers a taste of your writing style and how you might interact with clients and team members.
