Barrington James | Medical Writer

Principal Medical Writer & Regulatory Submissions

For a prominent organisation within the clinical trials sector, focusing on early-phase studies for pharmaceutical and biotechnology clients, is seeking a talented and experienced Principal Medical Writer with Regulatory Submissions. This role offers the opportunity to lead and manage teams within a dynamic, research-driven environment, dedicated to advancing medical innovation and supporting the development of transformative therapies.

Role Overview:

In this senior leadership position, you will be responsible for overseeing the preparation and delivery of high-quality regulatory submissions and medical writing outputs, ensuring adherence to all relevant regulatory standards. You will serve as the primary point of contact for internal teams and external sponsors, providing strategic advice on regulatory affairs and medical writing.

You will manage the complete regulatory process, liaising directly with sponsors, regulatory agencies, and ethics committees. You will ensure consistency, accuracy, and regulatory compliance across all documentation. Additionally, you will mentor junior team members and continuously update internal procedures and document templates to align with the latest regulatory guidelines.

Key Responsibilities:

• Lead recruitment efforts for the medical writing team, ensuring clear career progression and succession planning.
• Attend senior leadership pipeline meetings to align upcoming studies with organisational priorities and timelines.
• Monitor team performance, timesheets, and productivity to optimise resource allocation and billing accuracy.
• Support the growth of the Medical Writing and Regulatory Affairs department, contributing to the commercial success of the organisation.
• Regularly update process maps for medical writing and regulatory affairs to reflect evolving procedures.
• Collaborate with the commercial team to develop accurate pricing for medical writing and regulatory services, ensuring financially viable proposals.
• Continuously update SOPs to reflect changes in regulatory standards and industry best practices.
• Provide regular updates to senior management on changes to relevant regulatory frameworks.
• Offer expert regulatory advice to both sponsors and internal teams on submission strategies and requirements.
• Ensure the accurate preparation and timely submission of regulatory documents in line with all guidelines.

Medical Writing Responsibilities:

• Oversee the preparation and submission of study documentation, ensuring regulatory compliance and accuracy.
• Ensure factual accuracy and compliance with regulations across all written content in multiple projects.
• Demonstrate strong skills in scientific writing, editing, and data interpretation, producing clear and precise content.
• Contribute to business development initiatives, including participating in bid defence meetings as required.
• Work closely with senior management and quality assurance teams to drive continuous improvements in internal processes.

Qualifications and Experience:

• A minimum of 5 years’ experience in medical writing and regulatory submissions.
• Postgraduate qualification in a relevant scientific, medical, or life sciences field.
• Demonstrated experience with Phase I-III clinical trial submissions.
• Strong experience in mentoring and developing junior team members.
• Expertise in therapeutic areas such as cardiology, hepatology, gene therapies, and rare diseases is beneficial.
• A commercial mindset and prior experience working with business development teams would be advantageous.

This is a fantastic opportunity for a highly skilled professional looking to make a significant impact in the fields of medical writing and regulatory submissions. If you are interested, please apply directly or reach out for further information!