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- Tasks: Create high-quality scientific documents for pharmaceutical and biotech products.
- Company: Join a growing regulatory consultancy focused on science and technology.
- Benefits: Competitive salary, flexible working hours, and opportunities for professional growth.
- Why this job: Make a real impact in the pharmaceutical industry with your writing skills.
- Qualifications: Degree in life sciences; experience in medical writing preferred.
- Other info: Dynamic team environment with a focus on quality and accuracy.
The predicted salary is between 36000 - 60000 £ per year.
Join to apply for the Senior Regulatory Medical Writer role at Coronado Research. We are a growing Scientific and Technology led regulatory consultancy. To support our growth, 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.
Key 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.
Requirements:
- 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.
Additional Skills:
- 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.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Science
Industries: Pharmaceutical Manufacturing and Biotechnology Research
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 Senior Regulatory Medical Writer role!
✨Tip Number 2
Showcase your expertise! Create a portfolio of your best work, including any clinical study reports or regulatory documents you've authored. This will not only demonstrate your skills but also give potential employers a taste of what you can bring to their team.
✨Tip Number 3
Prepare for interviews by brushing up on your knowledge of regulatory guidelines and drug development processes. Be ready to discuss how your experience aligns with the responsibilities of the role. Confidence is key, so practice makes perfect!
✨Tip Number 4
Don’t forget to apply through our website! We’re always on the lookout for talented individuals like you. Keep an eye on our job postings and make sure your application stands out by tailoring it to the specific role you’re interested in.
We think you need these skills to ace Senior Regulatory Medical Writer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Medical Writer role. Highlight your relevant experience in medical writing and any specific projects that align with the job description. We want to see how your background fits perfectly with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory writing and how your skills can contribute to our team. Keep it concise but engaging, and don’t forget to mention your familiarity with regulatory guidelines.
Showcase Your Attention to Detail: As a medical writer, attention to detail is crucial. Make sure your application is free from typos and grammatical errors. We appreciate clarity and accuracy, so take the time to proofread your documents before submitting them through our website.
Highlight Relevant Skills: Don’t shy away from showcasing your skills! Mention your proficiency in Microsoft Office Suite and any experience you have with clinical trial documentation. We’re looking for someone who can interpret complex data and present it clearly, so let us know how you excel in this area.
How to prepare for a job interview at Coronado Research
✨Know Your Stuff
Make sure you brush up on your knowledge of regulatory requirements and the drug development process. Familiarise yourself with the types of documents you'll be writing, like clinical study reports and investigator brochures. This will show that you're not just a writer, but someone who understands the science behind it.
✨Showcase Your Experience
Prepare to discuss your previous experience in medical writing, especially in a pharmaceutical or biotech setting. Have specific examples ready that highlight your ability to produce high-quality documents and how you've tackled challenges in past projects. This will help demonstrate your expertise and fit for the role.
✨Attention to Detail is Key
Since this role requires a strong commitment to accuracy and quality, be ready to talk about how you ensure consistency and clarity in your writing. You might even want to bring along a sample of your work that showcases your attention to detail and adherence to regulatory guidelines.
✨Ask Insightful Questions
Interviews are a two-way street, so prepare some thoughtful questions about the company’s projects, team dynamics, and expectations for the role. This not only shows your interest but also helps you gauge if the company is the right fit for you.
