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- Tasks: Write and edit clinical documents while mentoring fellow writers in a dynamic environment.
- Company: Join an award-winning CRO known for its supportive and innovative culture.
- Benefits: Enjoy remote work flexibility, competitive salary, and career advancement opportunities.
- Why this job: Make a real impact in clinical research and shape the future of healthcare.
- Qualifications: 6+ years of regulatory writing experience and strong leadership skills required.
- Other info: Be part of a globally recognised team with exceptional employee satisfaction.
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, recognised 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, analyse, 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 clients to coordinate all facets of projects; competent communicator skills for projects.
- Contribute substantially to, or manage, 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 organisational 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) 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 you've led to the interview. We love seeing your work in action, and it gives you a chance to discuss your thought process and problem-solving skills directly related to the role.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can go a long way. It shows your enthusiasm for the position and keeps you fresh in their minds. And remember, apply through our website for the best chance at landing that role!
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 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 the 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 love candidates who are genuine and passionate about their work, so don’t hesitate to share what excites you about the role and our company culture.
Apply Through Our Website: We encourage you to apply directly through our website. This ensures your application gets to the right people quickly and shows us you’re serious about joining our innovative team at MMS.
How to prepare for a job interview at MMS Holdings Inc
✨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 medical writing.
✨Showcase Your Experience
Prepare to discuss your previous regulatory writing experience in detail. Be ready to share examples of projects you've led or contributed to, especially those involving aggressive timelines. Highlighting your ability to manage multiple tasks while maintaining quality will impress the interviewers.
✨Communication is Key
Since the role involves direct interaction with clients, practice articulating your thoughts clearly and confidently. Think about how you can demonstrate your competent communication skills during the interview. You might even want to prepare a few questions to ask them about their collaborative processes.
✨Cultural Fit Matters
MMS prides itself on its supportive and innovative culture. Research the company’s values and think about how your personal values align with theirs. During the interview, express your enthusiasm for being part of a team that shapes the future of clinical research, as this will resonate well with the interviewers.