Medical Writing and Regulatory Affairs Lead
1 week ago
About the Role
We are seeking a Medical Writing and Regulatory Affairs Lead to join our dynamic team at Barrington James.
In this role, you will be responsible for overseeing the preparation and delivery of high-quality regulatory submissions and medical writing outputs, ensuring adherence to all relevant regulatory standards.
The ideal candidate will have a strong background in medical writing and regulatory affairs, with a minimum of 5 years' experience in the industry.
The salary for this role is estimated at £90,000 - £110,000 per annum, depending on experience.
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.
- Expertise in therapeutic areas such as cardiology, hepatology, gene therapies, and rare diseases is beneficial.
- A commercial mindset and prior experience working with business development teams would be advantageous.
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