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 Senior Regulatory Medical Writer, you will play a critical role in ensuring the successful development and submission of regulatory documents to global health authorities.

You will collaborate closely with cross-functional teams, including clinical development, regulatory affairs, and scientific experts, to create accurate, concise, and compelling regulatory submissions.

Your expertise in medical writing and regulatory guidelines will contribute directly to our mission
of delivering safe and effective treatments to patients worldwide.

Key Duties and Responsibilities

Develop high-quality regulatory documents, including clinical study reports (CSRs), clinical summaries, safety narratives, investigator brochures, protocols, and sections of regulatory submissions

Collaborate with cross-functional teams to gather necessary information and data to support regulatory submissions.

Ensure compliance with regulatory guidelines, industry standards, and internal processes for document preparation and submission.

Conduct thorough research and analysis to generate well-structured and scientifically accurate content.

Review and edit documents to ensure clarity, consistency, and adherence to company standards.

Keep abreast of evolving regulatory requirements and guidelines to maintain a deep understanding of the global regulatory landscape.

Mentor and provide guidance to junior medical writers, fostering their professional growth and development.

Person Specification

Degree in life sciences, pharmacy, or a related field.

Minimum of 3 years of experience in regulatory medical writing within the pharmaceutical, biotechnology, or medical device industry.

Strong understanding of regulatory guidelines (e.g., FDA, EMA, ICH) and industry best practices.

Exceptional written and verbal communication skills, with the ability to translate complex scientific information into clear and concise language.

Detail-oriented approach, with excellent organizational and time management abilities.

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

Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously.

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