Principal Regulatory Writer

Principal Regulatory Writer

Edinburgh 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, providing class-leading writing support and consultancy services to the pharmaceutical industry. We produce a wide range of high-quality clinical documentation, including clinical study reports, protocols, clinical summaries, clinical overviews, regulatory responses, and other supporting documents across various 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. You will use your thorough knowledge of regulatory documents and development of submission documentation to lead complex submissions and guide other team members.

In this role, you will work as a trusted partner with various companies, providing high-level leadership and support on a range of project types and therapy areas. You will help maintain excellent client relationships, consult with clients, and demonstrate high-level strategic thinking to ensure effective medical writing for regulatory authorities.

This position offers an opportunity to build on your experience in regulatory writing while working within a highly specialised, supportive, and reputable team. 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 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 IPG Health Medical Communications, we pride ourselves on being an exceptional employer that fosters a supportive and innovative work culture. Our team of experts enjoys flexible working arrangements, uncapped paid time off, and a wealth of professional development opportunities, all while contributing to impactful medical communications in a dynamic environment. Join us to not only advance your career but also to be part of a diverse community dedicated to making 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 Principal Regulatory Writer

✨Tip Number 1

Familiarise yourself with the latest regulatory guidelines and standards in the pharmaceutical industry. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.

✨Tip Number 2

Network with professionals in the medical writing and regulatory fields. Attend industry conferences or webinars, and connect with current employees at Complete Regulatory on platforms like LinkedIn to gain insights into their work culture and expectations.

✨Tip Number 3

Prepare to discuss specific examples from your past experience where you've successfully led complex submissions or improved client relationships. This will showcase your strategic thinking and leadership skills, which are crucial for the Principal Regulatory Writer role.

✨Tip Number 4

Research Complete Regulatory's recent projects and achievements. Being knowledgeable about their work will allow you to tailor your conversation during interviews and show how your skills align with their goals and values.

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 Submission Documentation
Client Relationship Management
Ability to Work Under Pressure
Adaptability to Different Therapy Areas
Collaboration Skills

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 clinical documentation 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 or friend 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 others, showcasing your ability to take charge and support your colleagues.

✨Emphasise Client Relationship Management

Since maintaining excellent client relationships is crucial, be ready to talk about how you've built and nurtured client partnerships in previous roles. Discuss your approach to consulting with clients and ensuring their needs are met effectively.

✨Prepare for Strategic Thinking Questions

Expect questions that assess your strategic thinking abilities. Prepare to discuss how you approach problem-solving in regulatory writing and how your past experiences have shaped your decision-making process in high-pressure situations.

Principal Regulatory Writer
Complete Regulatory | An IPG Health Company
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