Lead Regulatory Writer
5 days ago
Barrington James is seeking a highly skilled Lead Regulatory Writer to join our Medical Writing and Regulatory Affairs department. As a senior leader, you will be responsible for overseeing the preparation and delivery of high-quality regulatory submissions and medical writing outputs.
With a strong background in medical writing and regulatory submissions, you will have a deep understanding of regulatory standards and be able to provide expert advice to both sponsors and internal teams. Your experience in managing teams and leading projects will enable you to drive business growth and develop accurate pricing for medical writing and regulatory services.
This is a fantastic opportunity for a highly skilled professional looking to take on a leadership role in the fields of medical writing and regulatory submissions. You will have the chance to work closely with senior management and quality assurance teams to drive continuous improvements in internal processes.
Key Responsibilities:
- Lead recruitment efforts for the medical writing team, ensuring clear career progression and succession planning.
- Attend senior leadership pipeline meetings to align upcoming studies with organisational priorities and timelines.
- Monitor team performance, timesheets, and productivity to optimise resource allocation and billing accuracy.
- Support the growth of the Medical Writing and Regulatory Affairs department, contributing to the commercial success of the organisation.
Requirements:
- A minimum of 5 years' experience in medical writing and regulatory submissions.
- Postgraduate qualification in a relevant scientific, medical, or life sciences field.
- Demonstrated experience with Phase I-III clinical trial submissions.
- Strong experience in mentoring and developing junior team members.
Estimated Salary: £65,000 - £90,000 per annum.
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