Head of Medical Writing and Regulatory Lead
2 weeks ago
We are seeking a highly skilled and experienced Head of Medical Writing and Regulatory to lead our team in delivering high-quality regulatory submissions and medical writing outputs.
The ideal candidate will have a strong background in medical writing and regulatory submissions, with experience in managing teams and ensuring compliance with regulatory standards. This is an excellent opportunity for someone looking to take on a senior leadership role in a dynamic and research-driven environment.
The estimated salary for this position is $120,000 - $180,000 per year, depending on experience.
About the RoleIn this senior leadership position, you will be responsible for overseeing the preparation and delivery of high-quality regulatory submissions and medical writing outputs. You will serve as the primary point of contact for internal teams and external sponsors, providing strategic advice on regulatory affairs and medical writing.
You will manage the complete regulatory process, liaising directly with sponsors, regulatory agencies, and ethics committees. You will ensure consistency, accuracy, and regulatory compliance across all documentation. Additionally, you will mentor junior team members and continuously update internal procedures and document templates to align with the latest regulatory guidelines.
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.
- Regularly update process maps for medical writing and regulatory affairs to reflect evolving procedures.
- Collaborate with the commercial team to develop accurate pricing for medical writing and regulatory services, ensuring financially viable proposals.
- Continuously update SOPs to reflect changes in regulatory standards and industry best practices.
- Provide regular updates to senior management on changes to relevant regulatory frameworks.
- Offer expert regulatory advice to both sponsors and internal teams on submission strategies and requirements.
- Ensure the accurate preparation and timely submission of regulatory documents in line with all guidelines.
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