Senior Regulatory Writer

Senior Regulatory Writer

Warrington Full-Time 43200 - 72000 £ / year (est.) Home office (partial)
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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 a creative and scientific edge.
  • 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: Ideal candidates are life-science graduates with regulatory writing experience; PhD preferred but not mandatory.
  • Other info: We celebrate diversity and encourage applicants from 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 focused on combining science, creativity, and technology to create exceptional medical communications solutions for 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
  • Other supporting documents

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, including strategic requirements such as clinical overviews, higher-level summaries, and briefing documents. You will also help to maintain excellent client relationships, allowing you to consult with clients and demonstrate 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 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 offering a range of world-class services and a flexible organisational structure. 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
  • Mental health wellness programme
  • Cycle to work scheme
  • Long Service Award
  • Season Ticket Loan
  • Flexible working

We celebrate diversity and encourage applicants from all backgrounds and/or disabilities. 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.

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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 of a Senior Regulatory Writer.

✨Tip Number 2

Network with professionals in the pharmaceutical industry or medical writing agencies. 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 past experiences in regulatory writing during the interview. Think of specific examples where you successfully navigated complex regulatory requirements or improved client relationships, as this will showcase your strategic thinking and expertise.

✨Tip Number 4

Research Complete Regulatory and IPG Health Medical Communications thoroughly. Understanding their values, culture, and recent projects will help you tailor your conversation and show that you're genuinely interested in being part of their team.

We think you need these skills to ace Senior Regulatory Writer

Regulatory Writing Experience
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
Ability to Work Under Pressure
Life Sciences Background
Research Experience
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 writing and the specific guidelines (FDA, EMA, ICH) that are relevant to the role.

Tailor Your CV: Highlight your relevant experience in regulatory writing and any life-science qualifications you possess. If you have a PhD or research experience, make sure to emphasise this, as it aligns well with the job requirements.

Craft a Compelling Cover Letter: Use your cover letter to showcase your passion for medical communications and your understanding of the pharmaceutical industry. Mention specific experiences that demonstrate your strategic thinking and ability to maintain 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 your documents 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 specific examples from your past roles that highlight your experience in regulatory writing. Discuss the types of documents you've worked on and how they contributed to successful outcomes for clients.

✨Emphasise Team Collaboration

Since this role involves coaching less experienced team members, be ready to talk about your collaborative experiences. Share instances where you’ve mentored others or worked closely with clients to achieve common goals.

✨Ask Insightful Questions

Prepare thoughtful questions about the company culture, team dynamics, and the specific challenges faced by the Regulatory Writing team. This shows your genuine interest in the role and helps you assess if it's the right fit for you.

Senior Regulatory Writer
Complete Regulatory | An IPG Health Company
C
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