Head of Medical Writing

2 months ago

London, UK, United Kingdom Arevna Full time

A leading Contract Research Organisation (CRO) specializing in early-phase clinical trials for pharmaceutical and biotechnology sponsors seeks to advance medical research and support the development of transformative therapies through excellence and innovation.


HYBRID - £70K+ - MUST BE SITE BASED 4 DAYS (CENTRAL LONDON).

MUST BE ABLE TO WORK IN THE UK WITHOUT NEED FOR VISA SUPPORT.


Position Overview

We are hiring a skilled Head of Medical Writing and Regulatory Submissions to lead our medical writing and regulatory teams. This senior-level position will oversee the production of high-quality regulatory submissions and medical documents, ensuring clarity, compliance, and adherence to regulatory standards. As a strategic advisor, you’ll provide key insights into regulatory affairs and medical writing for internal teams and external sponsors alike.

The role includes managing the medical writing and regulatory submissions processes, collaborating with sponsors, regulatory authorities, and ethics committees. You’ll be responsible for rigorous quality control, mentoring junior team members, and continuously updating Standard Operating Procedures (SOPs) and document templates in line with evolving regulatory guidelines.

Your leadership will drive successful project outcomes, foster sponsor satisfaction, and ensure our organisation maintains a forefront position in medical writing and regulatory submissions.


Key Responsibilities

  • Lead recruitment efforts within Medical Writing, establishing clear career progression and succession plans.
  • Participate in leadership meetings to manage and align study timelines with organisational priorities.
  • Track productivity and timesheets to support appropriate billing and resource allocation.
  • Monitor team performance and capability in alignment with annual objectives.
  • Drive the development and commercialisation of the Medical Writing and Regulatory Affairs department.
  • Build an organisation-wide understanding of Medical Writing and Regulatory Affairs.
  • Ensure regular updates of medical writing and regulatory process maps.
  • Collaborate with the commercial team to accurately cost and quote medical writing and regulatory services, supporting financially sound project proposals.
  • Update SOPs continuously, ensuring alignment with new regulatory standards and best practices.


Regulatory Affairs

  • Stay current with regulatory frameworks and provide regular updates to senior management on important regulatory changes.
  • Advise sponsors on regulatory submissions and medical writing strategies, ensuring alignment with regulatory best practices.
  • Maintain overall regulatory compliance and provide insights into the business impact of regulatory changes.
  • Provide regulatory expertise to project teams throughout the clinical trials process.
  • Support the organisation and preparation of regulatory submissions, ensuring accuracy and appropriateness.
  • Work closely with Clinical Project Delivery to maintain databases of regulatory information.


Medical Writing

  • Oversee the preparation and submission of all study documentation in accordance with regulatory requirements.
  • Ensure accuracy and compliance in all content development.
  • Apply a strong understanding of scientific principles to medical writing tasks.
  • Showcase scientific writing, editing, and data comprehension skills across varied projects.
  • Support business development activities, attending bid defence meetings as needed.
  • Collaborate with CPI to improve efficiency and update processes.
  • Contribute to developing and executing the publication strategy, with significant input in authorship.


Qualifications and Experience

  • At least five years of relevant experience and a related postgraduate qualification.
  • Degree in a scientific, medical, or life sciences field.
  • Proven experience with regulatory submissions (Phase I-III).
  • Demonstrated success in training and mentoring junior staff.
  • Experience in commercialising Medical Writing/Regulatory Affairs or collaborating with BD for this outcome (Desirable).
  • Expertise in key areas such as cardiology, hepatology, gene therapies, rare diseases, etc.
  • Publication record in peer-reviewed journals (searchable on PubMed).

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