Medical Writing and Regulatory Expert
9 hours ago
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.
- 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.
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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