At a Glance
- Tasks: Write and edit clinical documents that shape the future of medical research.
- Company: Join an award-winning CRO known for its supportive and innovative culture.
- Benefits: Enjoy remote work, competitive salary, and a focus on professional growth.
- Other info: Be part of a Great Place to Work certified organisation with excellent career advancement opportunities.
- Why this job: Make a real impact in the pharmaceutical industry while working with a collaborative team.
- Qualifications: 3-5 years of regulatory writing experience and a strong scientific background 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.
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
MMS is an award-winning clinical research organization that values your contributions and fosters a supportive, innovative work culture. As a Great Place to Work certified company, we offer exceptional employee retention rates, opportunities for professional growth, and a collaborative environment where you can thrive while working remotely from the UK. Join us to be part of a team that is shaping the future of clinical research and enjoy the benefits of a data-focused approach in the pharmaceutical, biotech, and medical device industries.
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 your connections in the pharmaceutical and biotech industries. Attend virtual events or webinars where you can meet potential colleagues and learn more about the company culture at MMS.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of clinical research and regulatory writing. Be ready to discuss your previous experiences and how they align with the responsibilities of the Senior Medical Writer role.
✨Tip Number 3
Showcase your writing skills! Bring samples of your previous work to the interview, especially those that demonstrate your expertise in regulatory documents. This will give the hiring team a taste of what you can bring to 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 your enthusiasm for joining a company that values innovation and collaboration.
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 documents, 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 joining MMS and how your background aligns with our mission. Keep it concise but impactful!
Showcase Your Experience:When detailing your experience, focus on specific projects where you’ve led or contributed significantly. Mention any regulatory submissions you’ve been involved with, as this will resonate well with us.
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 the role. Plus, you’ll get to explore more about our amazing culture!
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 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 how you've managed projects or mentored others, as this aligns perfectly with what they're looking for.
✨Be Ready to Discuss Collaboration
Since MMS values a collaborative environment, think of examples where you've worked effectively in a team. Highlight your communication skills and how you've interacted with clients or other departments to get the job done.
✨Ask Insightful Questions
Prepare some thoughtful questions about the company culture and their approach to clinical research. This shows your genuine interest in the role and helps you determine if it's the right fit for you. Plus, it gives you a chance to engage with your interviewers!
