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Role Filled
Regulatory Writer
Healthcare Communications
Medical Writer Scientific Dir
Medical Communications
Remote
Up to £42,000 D.O.E
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.
Company Information
This agency is home to the world’s 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 Requirements
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 Specifications
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
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Previous Listing
Date Updated
29 Nov 2023
Job reference
71678
Categories
Full Time
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