Head of Medical Writing and Regulatory Submissions

2 weeks ago

London London London London, UK, United Kingdom Richmond Pharmacology Full time
Job Title: Head of Medical Writing and Regulatory Submissions

Location: London Bridge (Hybrid 4 Days onsite)

Term: Permanent, Full-time

Salary: Competitive Salary + Benefits (Private Medical, Private Dental, Pension, 25 days Annual leave plus bank holidays & Many more)

Richmond Pharmacology 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, we strive to advance medical research and contribute to the development of life-changing therapies.

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. You will serve as a key advisor to both internal teams and external sponsors, providing strategic guidance on regulatory affairs and medical writing.

As a leader, you will manage the entire medical writing and regulatory submissions process, liaising directly with sponsors, regulatory authorities and ethics committees. You will be responsible for high-level Quality Control (QC) across all documents, ensuring consistency and regulatory compliance. Additionally, this role involves 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.

Your leadership and expertise will drive the success of projects, foster sponsor satisfaction and ensure Richmond Pharmacology remains at the forefront of medical writing and regulatory submissions.

Key Responsibilities:
  • Lead recruitment of people into the Medical Writing department with clear career progression and succession planning.
  • Attend pipeline meetings with senior leadership to forecast and manage upcoming studies, ensuring alignment with organisational priorities and timelines.
  • Monitor timesheets and productivity of their team. This will be used to support appropriate billing and resourcing.
  • 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.


Regulatory Affairs
  • Maintain up to date knowledge of relevant regulatory frameworks and guidance.
  • Provide quarterly updates to senior management and other appropriate teams on important regulatory/guideline changes and lead efforts to effect changes.
  • Provide expert advice and consultation to sponsors on regulatory affairs, submissions and medical writing strategies, ensuring alignment with regulatory requirements and best practices.
  • Ensure overall compliance with regulatory requirements and guidance.
  • Advise on business impacts of new regulatory requirements or guidance.
  • Provide regulatory expertise to project teams on all aspects of the clinical trials process.
  • Support the organisation and preparation of regulatory submissions, ensuring accuracy and regulatory appropriateness.
  • Work closely with Clinical Project Delivery to support the maintenance of filing and tracking databases of company regulatory information.


Medical Writing
  • Oversee the preparation, and submission, of all study documentation in accordance with regulatory requirements.
  • Ensure factual accuracy and regulatory compliance for all content development.
  • Demonstrate an advanced understanding of core scientific principles underpinning medical writing tasks.
  • Demonstrate excellent scientific writing, editing and data comprehension skills on a range of different project types, providing accurate and clear content.
  • Undertake content development with input and guidance from senior management and QA.
  • Support business development activities, attending bid defence meetings where required.
  • Engage with CPI to continuously update and improve processes and efficiency.
  • Play a key role in developing and enacting the business publication strategy. Providing significant contribution to authorship.


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.
  • Proven experience of submissions (Phase I-III).
  • 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.
  • Publication in peer reviewed journals (searchable on PubMed).


Application:

If you are interested in the 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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