Head of Medical Writing and Regulatory Submissions

4 weeks ago


London, Greater London, United Kingdom https:jobs-redefined.cositemap Full time

This is a senior leadership role that requires a strong background in medical writing and regulatory affairs. The successful candidate will oversee the preparation of high-quality regulatory submissions and medical writing deliverables, ensuring clarity, accuracy, and compliance with regulatory standards.

The ideal candidate will have a deep understanding of regulatory frameworks and guidelines, as well as excellent scientific writing, editing, and data comprehension skills. They will be responsible for mentoring and supervising less experienced team members and overseeing the continuous updating of Standard Operating Procedures (SOPs) and document templates to align with the latest regulatory guidelines.

This role involves leading the medical writing and regulatory submissions process, liaising directly with sponsors, regulatory authorities, and ethics committees. The successful candidate will be responsible for high-level Quality Control (QC) across all documents, ensuring consistency and regulatory compliance.

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

Key Responsibilities:

  • Lead the medical writing and regulatory submissions process, ensuring high-quality deliverables and regulatory compliance.
  • Maintain up-to-date knowledge of relevant regulatory frameworks and guidelines.
  • Provide expert advice and consultation to sponsors on regulatory affairs and medical writing strategies.
  • Oversee the preparation and submission of all study documentation in accordance with regulatory requirements.
  • Collaborate with the commercial team to ensure accurate costing and quoting of medical writing and regulatory services.

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.
  • GMC license.
  • Proven experience of submissions (Phase I-III).
  • Demonstrate having successfully contributed to training and progression of junior staff.

Application:

If you are interested in this role, please register your details, including a copy of your CV. Please note, while we try to respond to every candidate, the high volume of applications anticipated may make this impossible and we ask for your patience and understanding.



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