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- Tasks: Write and manage technical nonclinical documents for clinical research projects.
- Company: Join an award-winning CRO known for its supportive and innovative culture.
- Benefits: Enjoy remote work, competitive salary, and a great workplace environment.
- Why this job: Make a real impact in the pharmaceutical and biotech industries while advancing your career.
- Qualifications: Experience in regulatory writing and strong analytical skills required.
- Other info: Collaborative team atmosphere with opportunities for professional growth.
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.
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.
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 (eg, 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 analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, 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 meeting and CRMs
- Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars
- Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, 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, & the drug development process
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Senior Nonclinical Writer (Remote - UK) employer: MMS Holdings Inc
Contact Detail:
MMS Holdings Inc 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 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 the technical stuff!
✨Tip Number 3
Showcase your skills! Bring samples of your previous nonclinical documents to the interview. This will not only demonstrate your expertise but also give us a taste of your writing style and attention to detail.
✨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 there, so keep checking back!
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 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, FDA, and EMA. We love seeing candidates who can interpret complex data and have hands-on experience in the field.
Be Clear and Concise: When writing your application, clarity is key! Use straightforward language and avoid jargon unless necessary. We appreciate well-structured documents that get straight to the point, just like the nonclinical documents you'll be working on.
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 the role. Plus, you’ll find all the details about our company culture and values there!
How to prepare for a job interview at MMS Holdings Inc
✨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 biostatistics teams to demonstrate your ability to thrive in a team environment.
✨Demonstrate Your Regulatory Knowledge
Familiarise yourself with the latest ICH, FDA, and EMA guidelines relevant to nonclinical submissions. During the interview, confidently discuss how you’ve applied these regulations in your previous roles, as this will show that you’re not only knowledgeable but also proactive in staying updated with industry standards.
✨Prepare for Technical Questions
Expect to face technical questions related to pharmacokinetics, pharmacology, and toxicology data. Brush up on your analytical skills and be ready to interpret data from sources like bioanalytical reports. This will help you demonstrate your expertise and reassure the interviewers that you can handle the technical demands of the role.
