I am 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 £70K plus benefits package
Apply:
Please quote job reference 112567 in all correspondence.