Senior Regulatory and Medical Writer

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 and could be offered on a permanent, contract of part-time basis.

Candidates MUST have regulatory writing experience, this is not a medical communications 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.