Medical Writer

Salary: Competitive + Benefits (Private Medical, Private Dental, Pension,25 days Annual leave plus bank holidays& Many more)

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The Role:

You will be directly responsible for the generation of high-quality study documents, working across multiple projects simultaneously.

Key Responsibilities:

• Write and review various clinical and regulatory documents such as, but not limited to, clinical study protocols (CSPs), clinical study reports (CSRs), informed consent forms (ICFs), summary documents, advertising material and regulatory responses.
• Complete regulatory submissions (MHRA/REC/ARSAC) with minimal supervision from senior members of the team.
• Ensure all information is accurate, balanced, and compliant with regulatory requirements.
• Collaborate with senior writers and sponsors to develop and execute communication plans.
• Edit and proofread your own work and the work of others to ensure high quality and adherence to style guides.
• Manage multiple projects simultaneously and meet deadlines consistently.
• Stay up-to-date on current scientific advancements and regulatory changes.
• Attend internal and external training sessions to develop your medical writing skills and knowledge.
• Attend global sponsor meetings to discuss clinical trial set up, regulatory requirements, clinical study documents and submissions with a senior MW (as required).
• Coaches or mentors more junior staff on document planning, processes, and content.
• Contribute to the continuous improvement of internal processes and best practices.
• Acquire, maintain, and apply knowledge of all relevant industry, company, and regulatory guidelines (e.g. FDA, EMA, ICH, PMDA).
• Able to prepare the production of high-quality research papers, abstracts, and reports for publication in scientific journals.

Qualifications and Experience:

• At least 1 years of relevant clinical/regulatory medical writing experience is required.
• Excellent written and verbal communication skills with a demonstrated ability to write clearly, concisely and accurately for a variety of audiences.
• Proven ability to research and analyse complex scientific information.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and reference management software is essential.

Application:

If you are interested in the role, please register your details, including a copy of your CV. Please note, while we try to respond to every candidate, the high volume of applications anticipated may make this impossible and we ask for your patience and understanding.