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For Companies At a Glance
- Tasks: Write and edit high-quality scientific and regulatory documents for pharmaceuticals.
- Company: Dynamic regulatory consultancy focused on science and technology.
- Benefits: Flexible freelance role with competitive pay and the chance to work on impactful projects.
- Why this job: Join a growing team and contribute to the future of healthcare innovation.
- Qualifications: Degree in life sciences; experience in medical writing and regulatory documentation required.
- Other info: Work remotely with opportunities for professional growth in a supportive environment.
The predicted salary is between 36000 - 60000 £ per year.
Overview
We are a growing Scientific and Technology led regulatory consultancy. We are currently seeking a freelance Senior Regulatory & Scientific Writer to join our expanding team. You will be responsible for producing high-quality scientific and regulatory documents that support the development and commercialization of pharmaceutical and biotechnology products across a variety of therapeutic areas.
Responsibilities
- Review, develop, write, and edit various scientific and regulatory documents, including clinical study reports, investigator brochures, CTD modules, and briefing documents for EU & UK authorities.
- Ensure all documents comply with regulatory requirements, industry guidelines, and internal company standards.
- Participate in interpreting and planning data presentation for individual study reports and summary documents for nonclinical and clinical programs.
- Assist in responding to regulatory agency queries and document revisions as required.
- Perform quality control reviews of documents to ensure consistency, grammar, and adherence to templates.
- Ensure that all content meets the highest standards of clarity, accuracy, and scientific integrity.
- Provide scientific expertise in interpreting data and transforming it into clear documents and summaries.
Qualifications
- A degree in life sciences (e.g., Biology, Pharmacology, Medicine, or related fields) is required; an advanced degree (e.g., MSc, PhD, MD) is preferred.
- Extensive experience as a medical writer within a pharmaceutical, biotech, or CRO environment, with experience in authoring clinical and/or regulatory documentation.
- Familiarity with drug development processes, regulatory submission requirements, and guidelines.
- Experience with clinical trial documentation and regulatory submissions.
- Excellent written and verbal communication skills, with strong attention to detail and a commitment to accuracy and quality.
- Ability to interpret complex scientific data and present it in a clear and concise manner.
- Knowledge of clinical research terminology, medical literature, and regulatory guidelines.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
- Familiarity with medical publishing standards and platforms.
Additional Information
- Seniority level: Mid-Senior level
- Employment type: Freelance
- Location: London, England, United Kingdom
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Senior Regulatory Medical Writer employer: Coronado Research
Contact Detail:
Coronado Research Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Medical Writer
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and biotech industries. Attend relevant events or webinars, and don’t be shy about introducing yourself. You never know who might have a lead on that perfect freelance gig!
✨Tip Number 2
Showcase your expertise! Create a portfolio that highlights your best work in regulatory and scientific writing. Make sure it’s easy to access and share. This will give potential clients a taste of what you can do and set you apart from the competition.
✨Tip Number 3
Stay updated on industry trends! Follow key publications and join online forums related to regulatory writing. This not only keeps you informed but also gives you talking points during interviews or networking opportunities.
✨Tip Number 4
Apply through our website! We’re always on the lookout for talented writers like you. By applying directly, you’ll ensure your application gets the attention it deserves. Plus, it shows you’re genuinely interested in joining our team!
We think you need these skills to ace Senior Regulatory Medical Writer
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Regulatory Medical Writer role. Highlight your relevant experience in writing scientific and regulatory documents, and don’t forget to mention your familiarity with drug development processes!
Showcase Your Expertise: We want to see your scientific expertise shine through! When detailing your past roles, focus on how you've interpreted complex data and transformed it into clear, concise documents. This is your chance to show us what you can do!
Attention to Detail is Key: As a regulatory writer, accuracy is everything. Before submitting your application, double-check for any typos or grammatical errors. We’re looking for someone who values clarity and precision just as much as we do!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Coronado Research
✨Know Your Documents Inside Out
Before the interview, make sure you’re familiar with the types of documents you'll be working on, like clinical study reports and investigator brochures. Brush up on regulatory requirements and industry guidelines to show that you’re not just a writer, but a knowledgeable partner in the process.
✨Showcase Your Scientific Expertise
Be prepared to discuss your experience interpreting complex scientific data. Bring examples of how you've transformed intricate information into clear, concise documents. This will demonstrate your ability to provide scientific expertise, which is crucial for this role.
✨Highlight Attention to Detail
Since quality control is key in regulatory writing, share specific instances where your attention to detail made a difference. Whether it was catching a critical error or ensuring compliance with templates, these examples will illustrate your commitment to accuracy and quality.
✨Familiarise Yourself with Regulatory Agencies
Research the EU & UK regulatory agencies relevant to the role. Understanding their expectations and processes can give you an edge. Be ready to discuss how you would approach responding to agency queries or document revisions, showcasing your proactive mindset.