Principal Regulatory Writer

Principal Regulatory Writer

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

  • Tasks: Lead complex regulatory submissions and guide team members in medical writing.
  • Company: Join Complete Regulatory, part of IPG Health, a top-tier Med Comms agency.
  • Benefits: Enjoy flexible time off, retail discounts, private healthcare, and wellness programmes.
  • Why this job: Be part of a supportive team making a real impact in the pharmaceutical industry.
  • Qualifications: Previous experience as a regulatory writer in pharma or medical writing agency required.
  • Other info: Diversity is celebrated; adjustments for applicants are encouraged.

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

Complete Regulatory is part of IPG Health Medical Communications, home to the world’s most celebrated and awarded Med Comms agencies. We are 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 for experienced Principal Regulatory Writers with previous experience as a regulatory writer within the pharmaceutical industry and/or a medical writing agency to join our team and help us to build on our continuing success. You will use your thorough knowledge of regulatory documents and development of submission documentation to lead complex submissions and guide other team members.

Our clients value our services very highly and in this role you will work as a trusted partner with various companies, to provide high-level leadership and support on a range of project types and therapy areas. You will 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.

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

IPG Health Medical Communications is home to the world’s most celebrated and awarded med comms agencies, united by a healthy obsession with creating exceptional medical communications for our clients. Our people are the beating heart of our organisation, and through the positive culture we champion, our teams create communications that not only have a positive impact for our clients, but also impact on the world around us.

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.

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

At Complete Regulatory, part of the esteemed IPG Health Medical Communications, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our commitment to employee growth is evident through our extensive training programmes and flexible working options, allowing you to thrive in your career while enjoying benefits like uncapped paid time off and private healthcare. Join us in our vibrant location, where your expertise as a Principal Regulatory Writer will be valued, and together we can make a meaningful impact 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 Principal Regulatory Writer

✨Tip Number 1

Network with professionals in the pharmaceutical and medical writing fields. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in regulatory writing.

✨Tip Number 2

Familiarise yourself with the specific regulatory guidelines relevant to the therapy areas you are interested in. This knowledge will not only enhance your expertise but also demonstrate your commitment to the role during interviews.

✨Tip Number 3

Prepare to discuss your past experiences in leading complex submissions. Be ready to share specific examples of how you've successfully navigated challenges in regulatory writing, as this will showcase your strategic thinking.

✨Tip Number 4

Research Complete Regulatory and IPG Health Medical Communications thoroughly. Understanding their values, recent projects, and client relationships will help you tailor your discussions and show that you're genuinely interested in joining their team.

We think you need these skills to ace Principal Regulatory Writer

Regulatory Writing Expertise
Clinical Documentation Knowledge
Strong Understanding of Regulatory Guidelines
Project Management Skills
Attention to Detail
Excellent Communication Skills
Strategic Thinking
Ability to Lead and Mentor Team Members
Experience with Clinical Study Reports
Knowledge of Pharmaceutical Industry Standards
Client Relationship Management
Ability to Work Under Pressure
Adaptability to Changing Regulations
Collaboration and Teamwork

Some tips for your application 🫡

Understand the Role: Before applying, make sure you fully understand the responsibilities of a Principal Regulatory Writer. Familiarise yourself with the types of documents you'll be working on and the skills required for the role.

Tailor Your CV: Customise your CV to highlight relevant experience in regulatory writing within the pharmaceutical industry. Emphasise your knowledge of regulatory documents and any leadership roles you've held in past projects.

Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for medical communications and your strategic thinking abilities. Mention specific examples from your past experience that demonstrate your capability to lead complex submissions.

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 to review it before submission.

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

✨Showcase Your Regulatory Knowledge

Make sure to highlight your understanding of regulatory documents and submission processes during the interview. Be prepared to discuss specific examples from your past experience that demonstrate your expertise in producing clinical documentation.

✨Demonstrate Leadership Skills

As a Principal Regulatory Writer, you'll be expected to lead complex submissions and guide team members. Share instances where you've successfully led projects or mentored colleagues, showcasing your ability to take charge and support others.

✨Emphasise Client Relationship Management

Since maintaining excellent client relationships is crucial, prepare to discuss how you've built and nurtured client partnerships in previous roles. Highlight your strategic thinking and how it has positively impacted client outcomes.

✨Prepare for Scenario-Based Questions

Expect scenario-based questions that assess your problem-solving skills and decision-making abilities. Think about challenges you've faced in regulatory writing and how you overcame them, as this will demonstrate your critical thinking and adaptability.

Principal Regulatory Writer
Complete Regulatory | An IPG Health Company
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