Senior Regulatory Writer

Senior Regulatory Writer

Newcastle upon Tyne 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 in 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 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, and other supporting documents across various 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, including strategic requirements such as clinical overviews, higher-level summaries, and briefing documents. You will also help 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.

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 celebrates diversity and encourages 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.

Senior 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 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 role as a Senior Regulatory Writer while enjoying benefits like uncapped paid time off and private healthcare. Join us in a vibrant location where your contributions will not only advance your career but also 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 Senior Regulatory Writer

✨Tip Number 1

Familiarise yourself with the latest FDA, EMA, and ICH guidelines. This knowledge is crucial for a Senior Regulatory Writer, as it will help you demonstrate your expertise during interviews and discussions.

✨Tip Number 2

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

✨Tip Number 3

Prepare to discuss your previous experience in regulatory writing in detail. Be ready to share specific examples of documents you've worked on and how they contributed to successful client outcomes.

✨Tip Number 4

Showcase your ability to mentor and support less experienced team members. Highlight any coaching or training experiences you've had, as this aligns with the collaborative culture at Complete Regulatory.

We think you need these skills to ace Senior Regulatory Writer

Regulatory Writing Experience
Knowledge of FDA, EMA, and ICH Guidelines
Clinical Documentation Expertise
Strong Analytical Skills
Attention to Detail
Excellent Written Communication
Strategic Thinking
Client Relationship Management
Coaching and Mentoring Skills
Ability to Work Under Pressure
Time Management Skills
Collaboration and Teamwork
Adaptability to Changing Regulations
Research Skills

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights your experience as a regulatory writer in the pharmaceutical industry. Emphasise any relevant qualifications, such as a PhD or research experience, and showcase your knowledge of FDA, EMA, and ICH guidelines.

Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for medical writing and your understanding of the role. Mention specific examples of your past work that align with the responsibilities of a Senior Regulatory Writer.

Showcase Your Strategic Thinking: In your application, highlight instances where you have successfully consulted with clients or contributed to strategic documents. This will show your ability to think critically and strategically, which is essential for this role.

Proofread and Edit: Before submitting your application, thoroughly proofread all documents to ensure they are free from errors. A polished application reflects your attention to detail, which is crucial in regulatory writing.

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 Writing Skills

Prepare samples of your previous regulatory writing work to share during the interview. Highlight specific projects where you successfully navigated complex documentation requirements, as this will showcase your practical experience.

✨Emphasise Client Relationships

Be ready to discuss how you've maintained and built client relationships in past roles. This is crucial for the position, so provide examples of how your strategic thinking has positively impacted client outcomes.

✨Demonstrate Leadership Potential

Since the role involves coaching less experienced team members, think of examples where you've mentored or guided others. Highlight your ability to lead and support a team, which will be a key aspect of your contribution.

Senior Regulatory Writer
Complete Regulatory | An IPG Health Company
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