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Senior Regulatory and Medical Writer, Chesterfield
Client:
CK Group
Location:
Chesterfield, United Kingdom
EU work permit required:
Yes
Job Reference:
b18035fab414
Posted:
14.03.2025
Expiry Date:
28.04.2025
Job Description:
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:
* 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:
* 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 plus benefits package.
APPLY:
Please quote job reference 112 567 in all correspondence.
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