Senior Regulatory Writer

JR United Kingdom; High Wycombe; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading medical communications provider in High Wycombe seeks a Senior Regulatory Writer with a minimum of 3 years' experience. The role involves writing regulatory documents and maintaining client relationships while providing mentorship to junior writers. Applicants should have a life-science degree, ideally a PhD; knowledge of regulatory guidelines is essential. This position offers flexible working, uncapped paid time off, and a host of wellness programs.

Benefits

Flexible Time Off - uncapped paid time off

Retail and gym discounts

Great training and development

Employee assistance programme

Private healthcare

Mental health wellness programme

Cycle to work scheme

Season Ticket Loan

Flexible working

Qualifications

• At least 3 years' experience as a regulatory writer within the pharmaceutical industry.
• Proven ability to write various regulatory documents.
• Experience in maintaining client relationships.

Responsibilities

• Write a wide range of regulatory documents including clinical overviews and strategic requirements.
• Consult with clients to ensure effective medical writing.
• Provide coaching to less experienced team members.

Skills

Regulatory writing

Knowledge of FDA, EMA, and ICH guidelines

Strategic thinking

Coaching and mentoring

Education

Life-science degree, preferably PhD

Job description

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Complete Regulatory is part of IPG Health Medical Communications, who is 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.

What do we do?

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 at least 3 years' 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

· Employee assistance programme

· Private healthcare

· Headspace and MYNDUP - a mental health wellness programme

· Cycle to work scheme

· 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.