Company Information

This agency is home to the worlds most celebrated and awarded med comms agencies, united by a healthy obsession with creating exceptional medical communications for their clients.

Their people are the beating heart of the organisation, and through the positive culture they champion, their teams create communications that not only have a positive impact for our clients, but also impact on the world around us.

Role Overview

As a Medical Regulatory Writer, you will be at the forefront of our regulatory affairs efforts, responsible for creating accurate and persuasive regulatory documents that support the approval and commercialisation of our products.

You will collaborate closely with cross-functional teams, including regulatory affairs, clinical development, and scientific experts, to ensure compliance with global regulatory guidelines and deliver high-quality submissions.

This role offers an exciting opportunity to contribute to the advancement of healthcare through precise documentation and regulatory excellence.

Key Duties and Responsibilities

Develop, write, and edit a wide range of regulatory documents, including clinical study reports (CSRs), protocols, Investigational New Drug (IND) applications, New Drug Applications (NDAs), and marketing authorization applications.

Collaborate with cross-functional teams to gather and interpret scientific data, ensuring its accurate and comprehensive representation in regulatory documents.

Stay up to date with evolving global regulatory guidelines (e.g., FDA, EMA, ICH) to ensure compliance and contribute to the development of robust regulatory strategies.

Conduct thorough research to gather relevant scientific and clinical information, translating complex data into clear and concise language for regulatory submissions.

Collaborate with internal stakeholders to ensure consistency, accuracy, and adherence to established timelines for regulatory document preparation.

Review and edit documents to ensure clarity, coherence, and compliance with internal and external requirements.

Contribute to the development and maintenance of internal processes and standard operating procedures related to regulatory writing.

Stay informed about industry trends and best practices in medical regulatory writing, sharing insights and recommendations with the team.

Person Specification

Bachelor's degree or higher in life sciences, pharmacy, or a related field.

Minimum of 1.5 years of experience in medical regulatory writing within the pharmaceutical or biotechnology industry.

Strong knowledge of global regulatory guidelines (e.g., FDA, EMA, ICH) and the ability to interpret and apply them effectively.

Excellent written and verbal communication skills, with the ability to distill complex scientific information into clear and compelling narratives.

Attention to detail and strong organizational skills to manage multiple projects and meet deadlines.

Proficiency in using document management systems and relevant software (e.g., MS Office, Adobe Acrobat).

Ability to work collaboratively in a cross-functional environment, demonstrating strong teamwork and interpersonal skills.

Package

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