At a Glance
- Tasks: Write and manage technical nonclinical documents for regulatory submissions.
- Company: Join an award-winning CRO with a supportive and innovative culture.
- Benefits: Enjoy remote work, competitive salary, and a great workplace environment.
- 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: Opportunity for career growth in a dynamic, global organisation.
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 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 meeting 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, & the drug development process
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Nonclinical Writer (Remote - UK) Regulatory and MW - Nonclinical LONDON, ENGLAND, UNITED KINGDOM employer: MMS Holdings Inc
Contact Detail:
MMS Holdings Inc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Nonclinical Writer (Remote - UK) Regulatory and MW - Nonclinical LONDON, ENGLAND, UNITED KINGDOM
✨Tip Number 1
Network like a pro! Reach out to professionals in the industry through LinkedIn or local meetups. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to nonclinical writing. We recommend doing mock interviews with friends or using online platforms to boost your confidence.
✨Tip Number 3
Showcase your expertise! Create a portfolio of your best nonclinical documents and writing samples. This will help you stand out and demonstrate your skills to potential employers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are genuinely interested in joining our innovative team.
We think you need these skills to ace Nonclinical Writer (Remote - UK) Regulatory and MW - Nonclinical LONDON, ENGLAND, UNITED KINGDOM
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the 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 technical documents and collaborating with cross-functional teams.
Be Clear and Concise: When writing your application, clarity is key! We appreciate well-structured documents that are easy to read. Avoid jargon unless it’s relevant, and make sure your points are direct and to the point.
Apply Through Our Website: We encourage you to apply directly through our website. This not only streamlines the process but also ensures your application gets to the right people quickly. Plus, it shows us you're keen on joining our team!
How to prepare for a job interview at MMS Holdings Inc
✨Know Your Nonclinical Documents
Make sure you brush up on the specific 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 understand the role and can hit the ground running.
✨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 other departments to achieve a common goal.
✨Demonstrate Your Regulatory Knowledge
Familiarise yourself with the latest ICH, FDA, and EMA regulations. During the interview, mention how you’ve applied this knowledge in your previous roles, especially in relation to GLP and GCP guidelines. This will demonstrate your expertise and commitment to regulatory compliance.
✨Prepare Questions for Them
Interviews are a two-way street! Prepare thoughtful questions about the company culture, team dynamics, and the specific challenges they face in nonclinical writing. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
