Lead Medical Writer

We are seeking a medical doctor to join a highly professional and specialised company with a market-leading reputation for preparation of medical device regulatory submissions for a global client base. This role is suitable for doctors looking to make a first step into the medical device industry.

The successful applicant will be part of a dynamic, growing and innovative regulatory consulting company. Work will comprise leading teams of medical writers and reviewers in producing technical documents for medical device manufacturers, with a primary focus on EU MDR Clinical Evaluation Plans and Reports. Other roles include leading the preparation of a wide range of other technical documents, clinical investigation files, and preparation of submissions under EU MDR, IVDR and FDA.

The successful applicant will also play a leading role in the management of client projects, stemming from initial engagement, onboarding, leading communication throughout the project, and aftercare. The Lead Medical Writer will play a key role in ensuring on-time completion of projects to client satisfaction.

Key tasks

• Coordinating the production of documents for submission to various regulatory authorities
• Planning and execution of literature reviews
• Project management, timeline management and client engagement
• Resource allocation
• Document review and editing
• Revision management
• Direct engagement with company leadership to craft corporate strategy and decision-making

Essential requirements

• Qualified UK-based medical doctor in good standing with the GMC
• Extremely high standard of written English with meticulous attention to spelling, grammar and presentation
• High degree of familiarity with Microsoft Word and Excel
• Ability to communicate effectively with both team members and clients
• A self-starter with inherent ability to work independently and take the initiative
• Excellent organisational skills and attention to detail

This role will be office based working from the company HQ in Sheffield. While some home-working will be available, this role is not open to remote candidates. Full training will be provided.

Benefits

• The role offers fantastic exposure to the medical device industry
• Competitive salary and bonus + 3% employer pension contribution
• Opportunity for personal development and growth in a non-clinical environment
• Collaborative and supportive work environment
• Contribution to meaningful projects that impact healthcare innovation

This job description is intended to describe the general content and requirements of this position. It is not an exhaustive list of all duties and responsibilities. These may evolve based on the needs of the organisation and regulatory requirements.