Regulatory Medical Writer II

This is a fully remote position, open to applicants in United Kingdom, +3 more countries.

📋 Description

• Assume responsibility for complex Phase II-IV clinical regulatory documents.

• Oversee the entire document lifecycle from planning and engaging stakeholders to drafting, reviewing, and finalizing delivery.

• Create protocols, protocol outlines, informed consent forms (ICFs), investigator brochures, lay summaries, and regulatory briefing packages.

• Direct document planning, review, and approval processes across teams located in different regions.

• Analyze efficacy, safety, exposure, and endpoint data to produce clear scientific content.

• Foster alignment among cross-functional stakeholders and streamline the document development process.

• Manage timelines, address feedback, and ensure projects advance according to plan.

• Collaborate with Biostatistics, Data Management, Programming, Clinical Leadership, Project Physicians, and global Medical Writing teams.

⛳️ Requirements

• A minimum of 3 years of experience in regulatory medical writing.

• At least 1 year of experience in leading medical writing projects.

• Proven experience in independently authoring and managing clinical regulatory documents.

• Familiarity with ICH guidelines and regulatory requirements.

• Exceptional scientific communication and stakeholder management abilities.

• A degree in Life Sciences is mandatory.

• A PhD is preferred.

🏝️ Benefits

• Access to training, support, and a professional network to facilitate your growth.

• Opportunities to enhance scientific expertise or advance towards senior and leadership positions.

• Experience with global development programs.

• Collaboration with seasoned stakeholders across various functions.

• Ongoing development of project leadership skills.