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- Tasks: Write and edit clinical documents, ensuring scientific accuracy and regulatory compliance.
- Company: Join an award-winning CRO with a supportive and innovative culture.
- Benefits: Enjoy remote work, competitive salary, and opportunities for professional growth.
- Other info: Be part of a globally recognised organisation with excellent employee retention.
- Why this job: Make a real impact in clinical research while working with a collaborative team.
- Qualifications: 3-5 years of regulatory and clinical writing experience required.
The predicted salary is between 50000 - 65000 £ 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.
- At least 3 years of previous experience in the pharmaceutical industry.
- Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience.
- The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline.
- 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.
Senior Medical Writer (Remote - UK) in Manchester employer: MMS Holdings Inc
Contact Detail:
MMS Holdings Inc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer (Remote - UK) in Manchester
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and biotech industries. Attend relevant webinars or local meetups to get your name out there. Remember, sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Show off your expertise! Create a portfolio showcasing your best writing samples, especially those related to clinical documents. This will give potential employers a taste of your skills and help you stand out from the crowd.
✨Tip Number 3
Prepare for interviews by brushing up on your knowledge of regulatory guidelines and clinical practices. Be ready to discuss your previous projects and how you tackled challenges. Confidence is key, so practice makes perfect!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are genuinely interested in joining our innovative team at MMS.
We think you need these skills to ace Senior Medical Writer (Remote - UK) in Manchester
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Medical Writer role. Highlight your relevant experience in regulatory writing and clinical studies, and don’t forget to mention any specific projects that showcase your skills!
Showcase Your Writing Skills: Since exceptional writing skills are a must, consider including samples of your previous work or mentioning specific documents you've authored. This will give us a taste of your style and expertise right from the start.
Be Clear and Concise: When filling out your application, keep it straightforward. Use clear language and avoid jargon unless it's necessary. We appreciate candidates who can communicate effectively, just like you would in your writing assignments!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and our company culture 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 writing and regulatory documents. Familiarise yourself with the specific types of documents you'll be working on, like clinical protocols and study reports. This will not only help you answer questions confidently but also show that you're genuinely interested in the role.
✨Showcase Your Experience
Prepare to discuss your previous experience in the pharmaceutical industry, especially any leadership roles you've had in managing writing teams or projects. Be ready to share specific examples of how you've handled tight deadlines and complex regulatory submissions, as this will demonstrate your capability to thrive in a fast-paced environment.
✨Communicate Clearly
Since the role involves direct interaction with clients, practice articulating your thoughts clearly and concisely. You might want to prepare a few scenarios where you've successfully communicated complex information to non-experts. This will highlight your communication skills and ability to work collaboratively.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company culture and team dynamics. Inquire about how they support their writers and what opportunities there are for professional development. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.