Medical Writing and Regulatory Expert

9 hours ago


London, Greater London, United Kingdom Richmond Pharmacology Full time

We are seeking an experienced professional to lead our medical writing and regulatory teams. As a Senior Director, you will oversee the preparation of high-quality regulatory submissions and medical writing deliverables, ensuring clarity, accuracy, and compliance with regulatory standards.

Job Description:
  • Manage the entire medical writing and regulatory submissions process, liaising directly with sponsors, regulatory authorities, and ethics committees.
  • Responsible for high-level Quality Control (QC) across all documents, ensuring consistency and regulatory compliance.
  • Mentor and supervise less experienced team members and oversee the continuous updating of Standard Operating Procedures (SOPs) and document templates to align with the latest regulatory guidelines.
Required Skills and Qualifications:
  • At least 5 years of proven relevant experience in medical writing and regulatory affairs.
  • Relevant postgraduate qualification in a scientific, medical, or life sciences subject.
  • Demonstrated ability to train and develop junior staff.
Benefits:

This role offers a competitive salary range £70,000 - £90,000 per annum, depending on experience, plus benefits including private medical, dental, and pension schemes, as well as 33 days annual leave.



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