Senior Medical Writing Lead
4 days ago
We are seeking an accomplished Senior Medical Writing Lead to join our dynamic team at Barrington James. This exciting opportunity offers the chance to lead and manage teams within a fast-paced, research-driven environment dedicated to advancing medical innovation.
About the Role:
- As Senior Medical Writing Lead, you will oversee the preparation and delivery of high-quality regulatory submissions and medical writing outputs, ensuring adherence to all relevant regulatory standards.
- You will serve as the primary point of contact for internal teams and external sponsors, providing strategic advice on regulatory affairs and medical writing.
- Key responsibilities include managing the complete regulatory process, liaising directly with sponsors, regulatory agencies, and ethics committees, ensuring consistency, accuracy, and regulatory compliance across all documentation.
Requirements and Qualifications:
- A minimum of 5 years' experience in medical writing and regulatory submissions is essential.
- Postgraduate qualification in a relevant scientific, medical, or life sciences field is required.
- Demonstrated experience with Phase I-III clinical trial submissions is necessary.
- Strong experience in mentoring and developing junior team members is desirable.
- Expertise in therapeutic areas such as cardiology, hepatology, gene therapies, and rare diseases is beneficial.
Competitive Salary: £80,000 - £110,000 per annum
Benefits: Our comprehensive benefits package includes opportunities for career growth and professional development, flexible working arrangements, and a supportive work environment.
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