Medical Writing and Regulatory Lead

10 hours ago


London, Greater London, United Kingdom Richmond Pharmacology Full time

About Richmond Pharmacology:

We are a leading Contract Research Organisation (CRO) specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors. With a commitment to excellence and innovation, we strive to advance medical research and contribute to the development of life-changing therapies.

Location: London Bridge (Hybrid 4 Days onsite)

Term: Permanent, Full-time

Benefits:

  • Competitive Salary + Benefits (£80,000 - £100,000)
  • Private Medical, Private Dental, Pension, 25 days Annual leave plus bank holidays & Many more

About the Role:

We are seeking an experienced and accomplished Head of Medical Writing and Regulatory Submissions to lead and develop our medical writing and regulatory teams. In this senior role, you will play a pivotal part in overseeing the preparation of high-quality regulatory submissions and medical writing deliverables, ensuring clarity, accuracy, and compliance with regulatory standards.

Responsibilities:

  • 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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