Job Description
Location: London, Southwark (Hybrid – 4 Days Onsite)
Term: Permanent, Full-time
Salary: Competitive Salary + Benefits (Private Medical, Private Dental, Pension, 25 Days Annual Leave plus Bank Holidays & More)
I am currently working with a leading organisation in the clinical trials space, specialising in early-phase studies for pharmaceutical and biotechnology sponsors. They are committed to advancing medical research and supporting the development of life-changing therapies. They are now looking to recruit an experienced Head of Medical Writing and Regulatory Submissions to lead and manage their medical writing and regulatory teams.
Role Overview:
In this senior position, you will play a key role in overseeing the preparation of high-quality regulatory submissions and medical writing deliverables, ensuring compliance with all relevant regulatory standards. You will be the primary point of contact for both internal teams and external sponsors, offering strategic advice and guidance on regulatory affairs and medical writing.
As Head of Medical Writing and Regulatory Submissions, you will be responsible for managing the entire process, liaising directly with sponsors, regulatory bodies, and ethics committees. You will maintain high standards of quality and consistency across all documentation, ensuring full regulatory compliance. In addition, you will mentor and develop junior team members, while continuously updating SOPs and document templates to reflect the latest regulatory guidelines.
Key Responsibilities:
* Lead recruitment efforts for the medical writing department, establishing clear career progression paths and succession planning.
* Attend pipeline meetings with senior leadership to forecast and manage upcoming studies, ensuring alignment with organisational priorities and timelines.
* Monitor team performance, timesheets, and productivity to ensure appropriate billing and resource allocation.
* Drive the development of the Medical Writing and Regulatory Affairs department, supporting the commercialisation of services.
* Ensure the completion and ongoing updates of process maps related to medical writing and regulatory affairs.
* Work with the commercial team to accurately cost and quote medical writing and regulatory services, contributing to the development of financially sound proposals.
* Regularly update SOPs to reflect changes in regulatory guidelines, industry standards, and internal procedures.
* Stay up to date with relevant regulatory frameworks and provide quarterly updates to senior management on any important regulatory changes.
* Offer expert advice and consultation to sponsors and internal teams on regulatory requirements and submission strategies.
* Ensure the successful preparation and submission of regulatory documents, ensuring accuracy and compliance with guidelines.
Medical Writing Responsibilities:
* Oversee the preparation and submission of all study documentation, ensuring compliance with regulatory requirements.
* Ensure factual accuracy and regulatory compliance for all written content across various projects.
* Demonstrate proficiency in scientific writing, editing, and data comprehension, producing clear and accurate content.
* Contribute to business development activities, including attending bid defence meetings when required.
* Collaborate with senior management and quality assurance teams to continuously improve internal processes and efficiency.
Qualifications and Experience:
* At least 5 years of proven experience in medical writing and regulatory submissions.
* Postgraduate qualification in a relevant scientific, medical, or life sciences field.
* Proven experience in submissions for Phase I-III clinical trials.
* Experience in mentoring and developing junior staff.
* Knowledge of key therapeutic areas such as cardiology, hepatology, gene therapies, and rare diseases is desirable.
* A strong commercial mindset and experience working with business development teams would be advantageous.
This is a fantastic opportunity for an experienced individual looking to make a significant impact in the field of medical writing and regulatory submissions. If you are interested in this role, please apply directly or get in touch for more details.
Apply today:
gjohnstone@barringtonjames.com
+441293778666