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Clinical & Regulatory Medical Writer Specialist
2 months ago
We are seeking a highly skilled Clinical & Regulatory Medical Writer to join our team at Ipsen Biopharm Ltd. As a key member of our content creation team, you will be responsible for generating high-quality clinical documentation content, working across multiple accounts and projects seamlessly.
Main Responsibilities:- Manage the preparation of complex regulatory documents, including investigator brochures, protocols, CSRs, briefing documents, meeting requests, and CTD Clinical modules.
- Write and edit complex clinical documents, ensuring compliance with documentation quality standards, regulatory requirements, and consistency of messages across all documents.
- Represent the team in functional and cross-functional initiatives, networking and sharing best practices to ensure efficiency and consistency across product teams.
- Provide subject matter expertise in effective integration planning, implementation, and monitoring of integration activities within the CDO integration team.
- Work across multiple projects simultaneously, adhering to the quality control process and ensuring all work produced has gone through the correct internal review process.
- Demonstrate a good understanding of project management and resource planning, maintaining a working knowledge of pharmaceutical industry standards and compliance.
- Understand the purpose and role of communications in the wider therapy area and commercial landscape, demonstrating the ability to communicate clearly to different audiences through various media.
- Identify and communicate important therapy area updates and medical/regulatory milestones to the team and clients, providing regular feedback to senior teams across accounts and projects.
- Life sciences degree, preferably MSc or PhD, or equivalent combination of education and experience.
- Minimum 2 years Medical Writing experience in a CRO or pharmaceutical company, with working knowledge of ICH and US regulatory requirements.
- Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
- Recognised industry qualification in Medical Writing, such as the professional development qualifications provided by the American and European Medical Writing Associations.
- Proficient in using Microsoft Office, with an excellent command of the English language in both written and verbal communications.
