At a Glance
- Tasks: Write and manage technical nonclinical documents for innovative clinical research projects.
- Company: Join an award-winning CRO known for its supportive and inclusive culture.
- Benefits: Enjoy a competitive salary, remote work options, and career advancement opportunities.
- Other info: Be part of a dynamic environment with excellent employee retention and satisfaction.
- Why this job: Make a real impact in the pharmaceutical industry while working with a collaborative team.
- Qualifications: Experience in regulatory writing and strong analytical skills required.
The predicted salary is between 36000 - 60000 £ 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.
This person will participate in the development, writing, and management of highly technical nonclinical documents.
- Strong experience with development and writing of nonclinical documents (e.g., Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure (IB), Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs).
- Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity.
- Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data.
- Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents.
- Interpret and analyse applicable pharmacokinetics, pharmacology, and toxicology data (e.g., Prism files, bioanalytical reports, clinical pathology reports, PK / TK evaluation reports).
- Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC.
- Demonstrated ability to lead others to complete complex projects.
- Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines.
- Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment.
- Organisational expert within the nonclinical subject area.
- Excellent written/oral communication and strong time and project management skills.
- Ability to attend regular team meetings, lead client meetings and CRMs.
- Ability to work in various client systems (e.g., SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars.
- Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (e.g., ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP).
Requirements:
- BS+ in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control.
- Knowledge of GLP, ICH guidelines, and applicable regulatory requirements.
- 2+ years of pharmaceutical regulatory nonclinical writing experience.
- Strong writing and analytical skills.
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Basic understanding of CROs and scientific & nonclinical data/terminology, and the drug development process.
Senior Nonclinical Writer (Remote - UK) in England employer: MMS
At MMS, we are committed to fostering a supportive and innovative work environment where your contributions truly matter. As a Great Place to Work certified organisation, we offer exceptional employee retention rates, opportunities for professional growth, and a collaborative culture that empowers you to thrive in the dynamic field of clinical research. Join us remotely from the UK and be part of a team that is shaping the future of healthcare while enjoying the flexibility and benefits that come with working at a leading CRO.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Nonclinical Writer (Remote - UK) in England
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We think you need these skills to ace Senior Nonclinical Writer (Remote - UK) in England
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at MMS!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show MMS that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at MMS!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At MMS, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at MMS
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at MMS that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with MMS’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
