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- 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 flexibility, and career advancement opportunities.
- Why this job: Make a real impact in the pharmaceutical and biotech industries while working with a talented team.
- Qualifications: Experience in regulatory writing and strong analytical skills required.
- Other info: Be part of a global team shaping the future of clinical research.
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.
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 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)
- 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 in London employer: MMS
Contact Detail:
MMS Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Nonclinical Writer in London
✨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 job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory guidelines and nonclinical writing. We want to see that you can talk the talk and walk the walk when it comes to technical documents.
✨Tip Number 3
Showcase your skills! Bring samples of your previous work to interviews. This gives us a clear picture of your writing style and expertise in nonclinical documents, making you stand out from the crowd.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, you’ll find all the latest opportunities right there, tailored for you.
We think you need these skills to ace Senior Nonclinical Writer in London
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 any relevant projects you've led. We want to see how your skills align with what we're looking for!
Showcase Your Technical Skills: Since this role involves a lot of technical writing, be sure to mention your familiarity with regulatory guidelines like ICH and FDA. Include specific examples of documents you've authored, such as Investigator's Brochures or eCTD submissions, to demonstrate your expertise.
Keep It Clear and Concise: When writing your application, clarity is key! Use straightforward language and avoid jargon unless it's necessary. We appreciate well-structured documents that are easy to read, so make sure your application reflects that.
Apply Through Our Website: We encourage you to apply directly through our website. This way, your application will go straight to us, and we can review it promptly. Plus, you'll get a feel for our company culture while you're at it!
How to prepare for a job interview at MMS
✨Know Your Nonclinical Documents
Make sure you brush up on the specific types of nonclinical documents mentioned in the job description, like Module 2.4 and 2.6 eCTD submissions. Being able to discuss your experience with these documents will show that you’re not just familiar with the terminology but also understand their importance in the regulatory process.
✨Showcase Your Collaboration Skills
Since this role involves working with cross-functional teams, be prepared to share examples of how you've successfully collaborated in the past. Highlight any experiences where you led projects or worked closely with project management, safety, or regulatory operations to demonstrate your ability to thrive in a team environment.
✨Demonstrate Your Analytical Prowess
The job requires interpreting complex data, so be ready to discuss how you've handled pharmacokinetics, pharmacology, or toxicology data in previous roles. Bring specific examples of how you’ve analysed data and used it to inform your writing or decision-making processes.
✨Familiarise Yourself with Regulatory Guidelines
Understanding GLP, ICH, and other regulatory guidelines is crucial for this position. Before the interview, review these guidelines and think about how they apply to your past work. Being able to articulate your knowledge will show that you’re serious about compliance and quality in your writing.