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- Tasks: Write and manage technical nonclinical documents for regulatory submissions.
- Company: Join an award-winning CRO with a supportive and innovative culture.
- Benefits: Remote work, competitive salary, and opportunities for career advancement.
- Why this job: Make a real impact in clinical research while working with a collaborative team.
- Qualifications: Experience in regulatory writing and strong analytical skills required.
- Other info: Dynamic environment with excellent employee retention and growth opportunities.
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, 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.
This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position for candidates based out of the UK.
Roles and Responsibilities:- 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 the structure of Module 2.4 and 2.6 eCTD submission documents.
- Interpret and analyze 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.
- Organizational 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).
- 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, the drug development process.
Senior Nonclinical Writer – Remote UK employer: MMS
Contact Detail:
MMS Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Nonclinical Writer – Remote UK
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at MMS or similar companies. A friendly chat can open doors and give you insider info on what they’re really looking for.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory guidelines and nonclinical writing. We recommend practising common interview questions and even role-playing with a friend to boost your confidence.
✨Tip Number 3
Showcase your expertise! Bring samples of your previous work to the interview, especially those that align with the job description. This will demonstrate your ability to handle complex documents and your understanding of the industry.
✨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 being part of our innovative team at MMS.
We think you need these skills to ace Senior Nonclinical Writer – Remote UK
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Nonclinical Writer role. Highlight your experience with nonclinical documents and regulatory guidelines, as this will show us you understand what we're looking for.
Showcase Your Skills: Don’t just list your qualifications; demonstrate how your skills align with the job description. Use specific examples from your past work that relate to writing nonclinical documents and collaborating with cross-functional teams.
Be Clear and Concise: When writing your application, clarity is key! We appreciate well-structured documents that get straight to the point. Avoid jargon unless it’s relevant to the role, and make sure your writing reflects the high standards we uphold at MMS.
Apply Through Our Website: We encourage you to apply directly through our website. This ensures your application gets to the right place and allows us to review your details efficiently. Plus, it’s a great way to explore more about our company culture!
How to prepare for a job interview at MMS
✨Know Your Nonclinical Stuff
Make sure you brush up on your knowledge of nonclinical documents like Module 2.4 and 2.6 eCTD submissions. Be ready to discuss your experience with Investigator's Brochures and Nonclinical Study Reports, as well as how you've navigated regulatory guidelines in the past.
✨Showcase Your Leadership Skills
Since this role involves leading projects independently, think of examples where you've successfully managed complex writing tasks or led a team. Highlight your ability to collaborate with cross-functional teams and how you’ve driven projects to completion.
✨Be Ready for Technical Questions
Expect questions that dive deep into pharmacokinetics, pharmacology, and toxicology data. Brush up on interpreting bioanalytical reports and clinical pathology reports, and be prepared to explain how you would approach these in your writing.
✨Familiarise Yourself with Tools
Get comfortable with tools like SharePoint, Veeva RIM, and EndNote before the interview. Mention any hands-on experience you have with these systems, as it shows you're ready to hit the ground running in a remote environment.
