Senior Regulatory Writer

Senior Regulatory Writer

Full-Time 48000 - 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 consult with clients.
  • Company: Join IPG Health Medical Communications, 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 regulatory writing skills while making a real impact in a diverse and positive culture.
  • Qualifications: 3+ years of regulatory writing experience; life-science degree preferred, PhD or research experience is a plus.
  • Other info: We celebrate diversity and encourage applicants from all backgrounds to apply.

The predicted salary is between 48000 - 72000 £ per year.

Who are we?

Complete Regulatory is part of IPG Health Medical Communications, who is home to the world’s most celebrated and awarded Med Comms agencies. IPG Health Medical Communications comprises 800 experts obsessed with combining science, creativity, and technology to create exceptional medical communications solutions for our clients.

What do we do?

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.

The role

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.

What will you get in return?

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

To Apply or Contact Us

Apply by clicking the link below.

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.

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 Senior Regulatory Writers benefit from flexible time off, comprehensive training and development opportunities, and a supportive environment that encourages professional growth while making a meaningful impact in the pharmaceutical industry. Join us to be part of a diverse team dedicated to excellence in medical communications, where your contributions are valued and rewarded.
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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

Familiarize yourself with the latest FDA, EMA, and ICH guidelines. This knowledge is crucial for a Senior Regulatory Writer role, 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 more about the current trends in regulatory writing.

✨Tip Number 3

Prepare to discuss specific examples of your past work that showcase your strategic thinking and client relationship management skills. Highlighting these experiences can set you apart from other candidates.

✨Tip Number 4

Research Complete Regulatory and IPG Health Medical Communications thoroughly. Understanding their values, culture, and recent projects will allow you to tailor your conversations and show genuine interest in joining their team.

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
Life Sciences Background
Pharmaceutical Industry Experience
Research Experience
Excellent Communication Skills
Ability to Work Independently and as Part of a Team
Time Management Skills
Adaptability to Changing Requirements

Some tips for your application 🫡

Understand the Role: Make sure you fully understand the responsibilities and requirements of a Senior Regulatory Writer. Familiarize yourself with the types of documents you will be writing and the guidelines you need to follow, such as FDA, EMA, and ICH.

Tailor Your CV: Highlight your relevant experience in regulatory writing within the pharmaceutical industry or medical writing agencies. Include specific examples of documents you have worked on and any strategic contributions you made.

Craft a Compelling Cover Letter: In your cover letter, express your passion for medical communications and your understanding of the importance of regulatory writing. Mention how your background and skills align with the company's mission and values.

Showcase Your Knowledge: During the application process, demonstrate your thorough knowledge of regulatory guidelines and your ability to consult effectively with clients. This can be done through examples in your CV or cover letter that illustrate your strategic thinking and past experiences.

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 FDA, EMA, and ICH guidelines during the interview. Prepare specific examples of how you've applied these regulations in your previous work to demonstrate your expertise.

✨Demonstrate Strategic Thinking

Be ready to discuss your experience with strategic writing requirements, such as clinical overviews and briefing documents. Share instances where your strategic insights led to successful outcomes in regulatory submissions.

✨Emphasize Team Collaboration

Since this role involves coaching less experienced team members, be prepared to talk about your collaborative experiences. Highlight any mentoring or leadership roles you've taken on in past positions.

✨Prepare Questions for Them

Show your interest in the company by preparing thoughtful questions about their projects, team dynamics, and future goals. This not only demonstrates your enthusiasm but also helps you assess if the company is the right fit for you.

Senior Regulatory Writer
Complete Regulatory | An IPG Health Company
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