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- 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 great work-life balance.
- Other info: Be part of a team shaping the future of healthcare with excellent growth opportunities.
- Why this job: Make a real impact in clinical research while advancing your career in a collaborative environment.
- Qualifications: 3-5 years of regulatory writing experience and a strong background in medical or clinical disciplines.
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 Belfast 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 Belfast
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical writing field on LinkedIn or at industry events. A friendly chat can open doors and give you insights into opportunities that might not be advertised.
✨Tip Number 2
Showcase your expertise! Create a portfolio of your best writing samples, especially those related to clinical documents. This will demonstrate your skills and experience to potential employers, making you stand out.
✨Tip Number 3
Prepare for interviews by brushing up on your knowledge of regulatory guidelines and clinical practices. Be ready to discuss how your experience aligns with the responsibilities of the Senior Medical Writer role at MMS.
✨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 Senior Medical Writer (Remote - UK) in Belfast
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Medical Writer role. Highlight your relevant experience in regulatory writing and clinical studies, and don’t forget to showcase your exceptional writing skills!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about clinical research and how your background makes you a perfect fit for our innovative team at MMS.
Showcase Your Experience: When detailing your experience, focus on specific projects where you’ve led or contributed significantly. Mention any regulatory submissions you’ve worked on and how you managed timelines effectively.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and get you one step closer to joining our fantastic team!
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. This will show that you're not just a good writer, but also understand the science behind it.
✨Showcase Your Experience
Prepare to discuss your previous roles in the pharmaceutical industry, especially any leadership experience you have. Be ready to share specific examples of projects you've led or contributed to, particularly those involving regulatory submissions. This will help demonstrate your capability to handle the responsibilities of the role.
✨Communication is Key
Since the role involves interacting directly with clients, practice articulating your thoughts clearly and confidently. Think about how you can convey complex information simply and effectively. Good communication skills are essential, so be prepared to showcase this during your interview.
✨Cultural Fit Matters
MMS prides itself on its supportive and collaborative culture. Research their values and think about how your personal work style aligns with theirs. Be ready to discuss how you can contribute to a positive team environment, as this will resonate well with the interviewers.