Chief Medical Writing and Regulatory Affairs Director
12 hours ago
Overview:
Richmond Pharmacology, a leading Contract Research Organisation (CRO), is seeking an experienced Head of Medical Writing and Regulatory Submissions to lead and develop our medical writing and regulatory teams.
Salary: Competitive Salary + Benefits (£80,000 - £100,000)
About the Role:
We are looking for a skilled professional to oversee the preparation of high-quality regulatory submissions and medical writing deliverables. As a leader, you will manage the entire medical writing and regulatory submissions process, liaising directly with sponsors, regulatory authorities, and ethics committees.
- Lead recruitment of people into the Medical Writing department with clear career progression and succession planning.
- Monitor performance and capability of team in line with annual business objectives.
- Drive the capability development of the Medical Writing and Regulatory Affairs department with the goal of commercialisation.
- Accountability for building a good working knowledge of Medical Writing and Regulatory Affairs within the wider organisation.
- Ensure completion and ongoing updates of all medical writing/regulatory relevant process maps.
- Collaborate with the commercial team to ensure that all medical writing and regulatory services are accurately costed and quoted, contributing to the development of financially sound project proposals.
- Regularly update Standard Operating Procedures (SOPs) to reflect the latest regulatory guidelines, industry standards, and organisational changes, ensuring continuous improvement and adherence to best practices.
Qualifications and Experience:
- At least 5 years of proven relevant experience and Relevant postgraduate qualification.
- Educated to degree level in a relevant scientific, medical or life sciences subject.
- Demonstrate having successfully contributed to training and progression of junior staff.
- Experience in commercialising Medical Writing / Regulatory Affairs or working with BD to achieve the outcome (Desirable)
- Experience and knowledge of key subject areas i.e. cardiology, hepatology, gene therapies, rare diseases etc.
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