Senior Regulatory And Medical Writer

CK Group are recruiting for a 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 and candidates looking for permanent, contract or part-time roles will be considered.

RESPONSIBILITIES:

1. 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.
2. Preparation of clinical documents such as clinical study protocols and amendments, clinical study reports, and investigator's brochures/investigator's brochure updates.
3. Preparation of EU and US regulatory documents.
4. Project management.
5. Managing the document review process.
6. Organizing the quality control (QC) review of documents and addressing QC comments.
7. Editorial support and formatting of documents authored by other team members as required.
8. Peer review of documents authored by other colleagues.
9. Providing guidance and training to less experienced medical writers and members of the wider team.

QUALIFICATIONS:

1. 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).
2. Excellent written and verbal communication skills, including the ability to articulate ideas clearly, engage with diverse audiences, and produce error-free written content.
3. Proficient in Microsoft Office with excellent skills in Word.
4. Experience in preparing clinical documents.
5. Significant experience with the preparation of EU and US regulatory documents would be a distinct advantage.
6. Project management skills, including the creation and maintenance of project timelines and liaison with clients.

BENEFITS:

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

APPLY:

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