Head of Medical Writing and Regulatory Submissions

The Head of Medical Writing and Regulatory Affairs provides a senior level of expertise and management for the medical writing team.

They will be responsible for the fulfilment of medical writing and regulatory activities, ensuring optimal allocation of medical writing and regulatory resources.

Responsibilities:

• Take full accountability of all medical writing and regulatory activities.
• Direct line management responsibilities for the Medical Writing team. You will be managing two employees
• Provide regulatory expertise to project teams on all aspects of the clinical trials process.
• Support the organisation and preparation of regulatory submissions, ensuring accuracy and regulatory appropriateness.
• Oversee the preparation, and submission, of all clinical study documentation in accordance with regulatory requirements.
• Establish and maintain excellent sponsor relationships.

Required experience:

• 5-10 years of experience authoring pharmaceutical regulatory documentation, across phases I-III
• Line management experience desired