Senior Regulatory and Medical Writer

CK Group are recruiting for a permanent Senior Regulatory and Medical Writer to join a leading, dynamic and fast-growing consultancy on a permanent basis. They specialise in Advanced Therapies and Rare Diseases. This will be a fully remote role.

RESPONSIBILITIES:

Working as part of the medical writing team, you will be supporting the regulatory affairs, clinical operations and medical affairs teams across a range of projects, and directly with clients for standalone medical writing projects.

• Preparation of clinical documents such as clinical study protocols and amendments, clinical study reports, and investigator s brochures/investigator s brochure updates.
• Preparation of EU and US regulatory documents.
• Project management.
• Managing the document review process.
• Organizing the quality control (QC) review of documents and addressing QC comments.
• Editorial support and formatting of documents authored by other team members as required.
• Peer review of documents authored by other colleagues.
• Providing guidance and training to less experienced medical writers and members of the wider team.

QUALIFICATIONS:

As Senior Regulatory and Medical Writer you will require:

• Proven experience gained in a consultancy environment, with a minimum of a B.Sc. in a life sciences subject (a higher degree would be a distinct advantage).
• Excellent written and verbal communication skills, including the ability to articulate ideas clearly, engage with diverse audiences, and produce error-free written content.
• Proficient in Microsoft Office with excellent skills in Word.
• Experience in preparing clinical documents.
• Significant experience with the preparation of EU and US regulatory documents would be a distinct advantage.
• Project management skills, including the creation and maintenance of project timelines and liaison with clients.

BENEFITS:

Salary of up to £70,000 per annum, plus benefits package.


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