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For Companies 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.
- 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 strong organisational skills required.
- Other info: Be part of a dynamic environment with opportunities to mentor and lead.
The predicted salary is between 36000 - 60000 £ per year.
Overview
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, recognized 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. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
We are looking for a full-time employee, remotely based within the UK.
Responsibilities
- Under minimal supervision, the Medical Writer will critically evaluate, analyze, 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 client to coordinate all facets of projects; competent communicator skills for projects
- Contribute substantially to, or manages, 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
- 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 organizational 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
- Substantial clinical study protocol experience, as lead author, required
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- Not required, but experience with orphan drug designations and PSP/PIPs a plus
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Senior Medical Writer (Remote - UK) Regulatory and MW - Regulatory Submissions Writing LONDON, [...] 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) Regulatory and MW - Regulatory Submissions Writing LONDON, [...]
✨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
Prepare for those interviews! Research MMS thoroughly and understand their culture and values. Think about how your experience aligns with their mission and be ready to share specific examples of your work that demonstrate your skills.
✨Tip Number 3
Show off your writing skills! Bring samples of your previous regulatory documents to the interview. This will not only showcase your expertise but also give you a chance to discuss your thought process and approach to 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 you’re genuinely interested in joining our innovative team at MMS.
We think you need these skills to ace Senior Medical Writer (Remote - UK) Regulatory and MW - Regulatory Submissions Writing LONDON, [...]
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 this role and how your background aligns with our mission at MMS. Keep it concise but impactful!
Showcase Your Experience: When detailing your experience, focus on specific projects where you’ve led or contributed to regulatory submissions. Mention any successful outcomes and how you managed timelines effectively.
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 this exciting opportunity 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 regulatory writing and clinical protocols. 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 the industry.
✨Showcase Your Experience
Prepare to discuss your previous roles in the pharmaceutical industry, especially any experience leading teams or managing projects. Be ready to share specific examples of how you've handled aggressive timelines and complex regulatory submissions. This will demonstrate your capability and confidence in the role.
✨Ask Insightful Questions
Interviews are a two-way street! Prepare thoughtful questions about the company culture, team dynamics, and the types of projects you might be working on. This not only shows your interest in the role but also helps you gauge if the company is the right fit for you.
✨Demonstrate Your Communication Skills
As a Medical Writer, clear communication is key. During the interview, focus on articulating your thoughts clearly and concisely. Practice explaining complex concepts in simple terms, as this will reflect your ability to communicate effectively with both clients and team members.
