Senior Medical Writer Lead
hace 3 días
**About Us**
Cmed Group Ltd is an international Contract Research Organization (CRO) with a unique position in the clinical research industry. We support biotech companies in clinical trials across all phases and non-interventional studies, focusing on oncology, cell & gene therapy, radiopharmaceuticals, and rare diseases.
We are currently looking for an enthusiastic and talented Senior Medical Writer Lead to join our team. This role is home-based in the UK or EU where we have the ability to hire.
**Job Overview**
The Senior Medical Writer Lead will perform medical writing tasks according to Aixial SOPs as applicable, and in accordance with sponsor contracts. The successful candidate will be responsible for coordinating and managing medical writing tasks, including timely delivery of high-quality documents.
**Responsibilities**
- Prepare documents such as clinical study reports, Investigator's Brochure updates, protocols, addendum reports, and summary documents for submission to regulatory authorities, ethics committees, and investigators.
- Prepare clinical investigation/evaluation reports for medical devices.
- Prepare scientific publications (conference abstracts, posters, and manuscripts).
- Keep updated in guidelines and requirements pertaining to medical writing.
- Maintain and develop skills within medical writing.
**Requirements**
- Ability to structure and plan own work according to agreed timelines.
- Ability to manage own time.
- Excellent attention to detail combined with an understanding of the document's overall purpose.
- Ability to work simultaneously on more than one project.
- Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
- Knowledge of GCP as well as relevant ICH guidelines.
**Preferred Qualifications**
- Good knowledge of Microsoft Office 365.
- Fluency in spoken and written English.
**Compensation Package**
The estimated salary for this position is £60,000 - £80,000 per annum, depending on experience. We also offer a range of benefits, including professional development opportunities and a supportive work environment.
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