Senior Regulatory Writer

Senior Regulatory Writer

Warrington Full-Time 43200 - 72000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Write high-quality regulatory documents for the pharmaceutical industry and support clients with strategic insights.
  • Company: Join Complete Regulatory, part of IPG Health, a leader in medical communications with 800 passionate experts.
  • Benefits: Enjoy flexible time off, retail discounts, private healthcare, and a supportive work environment.
  • Why this job: Advance your career in a reputable team while making a positive impact on healthcare communications.
  • Qualifications: Life-science graduates preferred; experience in regulatory writing is essential.
  • Other info: Diversity is celebrated here; we encourage all backgrounds to apply.

The predicted salary is between 43200 - 72000 £ per year.

Complete Regulatory is part of IPG Health Medical Communications, comprising 800 experts obsessed with combining science, creativity, and technology to create exceptional medical communications solutions for our clients.

At Complete Regulatory, we provide class-leading writing support and consultancy services to the pharmaceutical industry, producing a wide range of high-quality clinical documentation, including clinical study reports, protocols, clinical summaries, clinical overviews, regulatory responses and other supporting documents, across a variety of therapy areas.

We are looking to recruit Senior Regulatory Writers with previous experience as a regulatory writer within the pharmaceutical industry and/or a medical writing agency. Applicants should be life-science graduates, ideally with a PhD or other research experience, although this is not mandatory. You will use your thorough knowledge of FDA, EMA and ICH guidelines to write a wide range of regulatory documents; these will include strategic requirements, such as clinical overviews, higher-level summaries and briefing documents. You will also help to maintain our excellent client relationships, which will allow you to consult with the client and demonstrate your high-level strategic thinking, based on extensive past experience, to ensure effective medical writing for regulatory authorities. You will be a highly valued member of the Regulatory Writing team and will have the opportunity to advance your skills while helping less experienced team members to achieve their potential, by providing coaching and insight.

This position will benefit anyone looking to build on their experience in regulatory writing, while working within a highly specialised, supportive and reputable team. In addition, you will become part of a larger organisation, which offers a range of world-class services and a flexible organisational structure. As well as a fresh challenge in your career, long term career choices and development, you will be rewarded with:

  • Flexible Time Off – uncapped paid time off
  • Retail and gym discounts
  • Great training and development
  • Life assurance
  • Pension
  • Employee assistance programme
  • Private healthcare
  • Headspace and MYNDUP - a mental health wellness programme
  • Cycle to work scheme
  • Long Service Award
  • Season Ticket Loan
  • Flexible working

We celebrate diversity and encourage applicants from all whatever their background and/or disability. We want you to have every opportunity to shine and show us your talents, so please reach out and let us know if there are any reasonable adjustments we can make to ensure our assessment process works for you.

Senior Regulatory Writer employer: Complete Regulatory | An IPG Health Company

At Complete Regulatory, part of the esteemed IPG Health Medical Communications, we pride ourselves on fostering a dynamic and inclusive work culture that champions creativity and collaboration. Our Senior Regulatory Writers benefit from unparalleled professional development opportunities, flexible working arrangements, and a comprehensive benefits package, including uncapped paid time off and private healthcare. Join us in a vibrant location where your expertise will not only advance your career but also contribute to impactful medical communications that make a difference in the pharmaceutical industry.
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Contact Detail:

Complete Regulatory | An IPG Health Company Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Senior Regulatory Writer

✨Tip Number 1

Familiarise yourself with the latest FDA, EMA, and ICH guidelines. Being well-versed in these regulations will not only boost your confidence during interviews but also demonstrate your commitment to the role and industry.

✨Tip Number 2

Network with professionals in the pharmaceutical and medical writing fields. Attend relevant conferences or webinars to connect with potential colleagues and learn more about the current trends and challenges in regulatory writing.

✨Tip Number 3

Prepare to discuss your previous experiences in regulatory writing during the interview. Highlight specific projects where you successfully navigated complex regulatory requirements, as this will showcase your expertise and problem-solving skills.

✨Tip Number 4

Showcase your ability to mentor and support less experienced team members. Be ready to share examples of how you've helped others grow in their roles, as this aligns with the collaborative culture at Complete Regulatory.

We think you need these skills to ace Senior Regulatory Writer

Regulatory Writing
Knowledge of FDA, EMA, and ICH Guidelines
Clinical Documentation Expertise
Strategic Thinking
Client Relationship Management
Coaching and Mentoring Skills
Attention to Detail
Strong Communication Skills
Life Sciences Background
Research Experience
Ability to Work Under Pressure
Time Management Skills
Adaptability
Team Collaboration

Some tips for your application 🫡

Understand the Role: Before applying, make sure you fully understand the responsibilities of a Senior Regulatory Writer. Familiarise yourself with the types of documents you'll be expected to produce and the regulatory guidelines involved.

Tailor Your CV: Highlight your relevant experience in regulatory writing and any specific knowledge of FDA, EMA, and ICH guidelines. Make sure to include any life-science qualifications, especially if you have a PhD or research experience.

Craft a Compelling Cover Letter: Use your cover letter to showcase your passion for medical communications and your strategic thinking abilities. Mention how your past experiences align with the role and how you can contribute to maintaining excellent client relationships.

Proofread Your Application: Ensure that your application is free from errors. A well-written application reflects your attention to detail, which is crucial for a regulatory writer. Consider asking a colleague or friend to review it before submission.

How to prepare for a job interview at Complete Regulatory | An IPG Health Company

✨Know Your Guidelines

Familiarise yourself with FDA, EMA, and ICH guidelines before the interview. Being able to discuss these regulations confidently will demonstrate your expertise and understanding of the regulatory landscape.

✨Showcase Your Experience

Prepare to discuss specific examples from your past roles as a regulatory writer. Highlight your contributions to clinical documentation and how you maintained client relationships, as this will showcase your relevant experience.

✨Demonstrate Strategic Thinking

Be ready to explain how you approach writing strategic documents like clinical overviews and briefing documents. Discuss your thought process and how you ensure that your writing meets both regulatory requirements and client needs.

✨Emphasise Team Collaboration

Since you'll be part of a team, share examples of how you've coached or supported less experienced colleagues in the past. This will show your ability to work collaboratively and contribute to the development of others.

Senior Regulatory Writer
Complete Regulatory | An IPG Health Company
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