Senior Regulatory Medical Writer
Senior Regulatory Medical Writer

Senior Regulatory Medical Writer

Freelance 36000 - 60000 £ / year (est.) Home office (partial)
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At a Glance

  • Tasks: Write and edit high-quality scientific and regulatory documents for pharmaceuticals.
  • Company: A growing consultancy focused on science and technology in the regulatory field.
  • Benefits: Flexible freelance role with opportunities to work on impactful projects.
  • Why this job: Join a dynamic team and contribute to the future of healthcare innovation.
  • Qualifications: Degree in life sciences and 10+ years of medical writing experience required.
  • Other info: Ideal for detail-oriented individuals passionate about scientific communication.

The predicted salary is between 36000 - 60000 £ per year.

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.

Responsibilities

  • Review, develop, write, and edit various scientific and regulatory documents, including clinical study reports, investigator brochures, CTD modules, briefing documents for US, 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.
  • Minimum 10+ years’ 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.

Senior Regulatory Medical Writer employer: Pop Science

As a leading Scientific and Technology-led regulatory consultancy, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to excel. Our commitment to professional development ensures that you will have ample opportunities for growth and advancement in your career, while our focus on high-quality scientific integrity allows you to contribute meaningfully to the pharmaceutical and biotechnology sectors. Join us in a dynamic environment where your expertise will be valued and your contributions will make a real impact.
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Contact Detail:

Pop Science 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 the inside scoop on job openings!

✨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, so potential employers can see your skills in action.

✨Tip Number 3

Prepare for interviews by brushing up on industry trends and regulatory guidelines. Be ready to discuss how your experience aligns with the role of a Senior Regulatory Medical Writer. Confidence is key, so practice your pitch!

✨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.

We think you need these skills to ace Senior Regulatory Medical Writer

Scientific Writing
Regulatory Documentation
Clinical Study Reports
Investigator Brochures
CTD Modules
Data Presentation
Quality Control Reviews
Attention to Detail
Communication Skills
Life Sciences Knowledge
Drug Development Processes
Regulatory Submission Requirements
Microsoft Office Suite
Medical Publishing Standards

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! Include specific examples of documents you've authored or edited, especially those that comply with regulatory requirements. This will help us understand your depth of knowledge in the field.

Attention to Detail is Key: As a medical writer, accuracy is crucial. Before submitting your application, double-check for any typos or grammatical errors. We appreciate candidates who demonstrate a commitment to quality and clarity in their writing.

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, it shows you’re keen on joining our team!

How to prepare for a job interview at Pop Science

✨Know Your Documents Inside Out

Before the interview, make sure you’re familiar with the types of scientific and regulatory documents you'll be working on. Brush up on clinical study reports, investigator brochures, and CTD modules. Being able to discuss these confidently will show your expertise and readiness for the role.

✨Showcase Your Regulatory Knowledge

Understand the regulatory landscape, especially for US, EU, and UK authorities. Be prepared to discuss how you ensure compliance with regulatory requirements and industry guidelines in your writing. This will demonstrate your ability to navigate the complexities of regulatory submissions.

✨Highlight Your Attention to Detail

Since quality control is crucial in this role, come prepared with examples that showcase your meticulousness. Discuss how you’ve ensured clarity, accuracy, and adherence to templates in your previous work. This will reassure them that you can maintain high standards.

✨Prepare for Data Interpretation Questions

Expect questions about how you interpret complex scientific data and transform it into clear documents. Think of specific instances where you’ve successfully communicated intricate information. This will highlight your analytical skills and ability to present data effectively.

Senior Regulatory Medical Writer
Pop Science

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