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 dynamic team shaping the future of healthcare.
- Why this job: Make a real impact in clinical research while working with a collaborative team.
- Qualifications: 3-5 years of medical writing experience and strong organisational skills 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 a 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
Linked In .
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, Power Point, 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
Senior Medical Writer (Remote - UK) in Swansea employer: MMS
At MMS, we are dedicated to creating a workplace where your expertise as a Principal Biostatistician is valued and nurtured. Our award-winning culture promotes collaboration and innovation, ensuring that you have the support and resources needed to excel in your role while contributing to meaningful projects in the clinical research field. With a strong focus on employee growth and a commitment to maintaining an inclusive environment, MMS stands out as an exceptional employer in the UK.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Medical Writer (Remote - UK) in Swansea
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like MMS.
✨Tap into Professional Associations
Check out associations like the Institute of Healthcare Management. They often have job boards, networking events, and conferences that are perfect for connecting with potential employers in health sciences administration.
✨Stay Updated with Industry Trends
Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at MMS.
✨Apply Through Our Website for Better Visibility
When you find roles that excite you, especially at places like MMS, don’t forget to apply through our website. This can sometimes give you an edge by showing the employer you’re savvy and committed to finding the right fit.
We think you need these skills to ace Senior Medical Writer (Remote - UK) in Swansea
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at MMS.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at MMS.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to MMS. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at MMS. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at MMS
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research MMS’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
