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.
- 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 writing experience and a strong background in medical sciences.
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
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 and a collaborative environment where you can thrive and advance your career. Join us remotely in the UK and be part of a team that is shaping the future of clinical research while enjoying the benefits of a global footprint and industry-leading customer satisfaction.
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 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 best work to the interview. This will not only demonstrate your expertise but also give you a chance to discuss your thought process and approach to medical writing.
✨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 MMS and being part of our innovative team.
We think you need these skills to ace Senior Medical Writer (Remote - UK) in Manchester
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 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 the best chance of getting noticed. It’s the easiest way for us to see your application and get you into our exciting recruitment process!
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 examples of how you've managed timelines and mentored other writers. This will demonstrate your capability to take ownership of assignments and lead projects effectively.
✨Communicate Clearly
Since the role involves direct interaction with clients, practice articulating your thoughts clearly and confidently. Think about how you can convey complex information simply, as this is crucial for effective communication in medical writing.
✨Ask Insightful Questions
Prepare some thoughtful questions about MMS's culture, team dynamics, and their approach to clinical research. This shows your genuine interest in the company and helps you assess if it's the right fit for you. Plus, it gives you a chance to engage with your interviewers on a deeper level.
