At a Glance
- Tasks: Lead and manage regulatory submissions and medical writing in a dynamic research environment.
- Company: Join a prominent organization focused on advancing medical innovation in clinical trials.
- Benefits: Enjoy a collaborative culture, mentorship opportunities, and the chance to impact transformative therapies.
- Why this job: Make a significant impact in medical writing while supporting the development of groundbreaking therapies.
- Qualifications: 5+ years in medical writing, postgraduate degree, and experience with clinical trial submissions required.
- Other info: Opportunity to mentor junior writers and contribute to business development initiatives.
The predicted salary is between 48000 - 72000 £ per year.
Principal Medical Writer
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!
Principal Medical Writer employer: Barrington James
Contact Detail:
Barrington James Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Medical Writer
✨Tip Number 1
Familiarize yourself with the latest regulatory guidelines and standards in medical writing. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the clinical trials sector, especially those involved in regulatory submissions. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss your experience in mentoring junior team members and leading projects. Highlight specific examples where you've successfully guided others or improved processes, as this aligns with the leadership aspect of the role.
✨Tip Number 4
Showcase your expertise in therapeutic areas relevant to the position, such as cardiology or gene therapies. Being able to speak knowledgeably about these topics can set you apart from other candidates and demonstrate your value to the organization.
We think you need these skills to ace Principal Medical Writer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in medical writing and regulatory submissions. Emphasize your leadership roles, mentoring experience, and any specific therapeutic areas you have worked in.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for advancing medical innovation. Discuss your relevant experience, particularly in overseeing regulatory submissions and leading teams, and how it aligns with the company's mission.
Highlight Relevant Qualifications: Clearly outline your postgraduate qualifications and any certifications related to medical writing or regulatory affairs. Mention your experience with Phase I-III clinical trial submissions to demonstrate your expertise.
Showcase Leadership Skills: In your application, provide examples of how you have successfully led teams, mentored junior members, and contributed to process improvements. This will illustrate your capability to fulfill the senior leadership role.
How to prepare for a job interview at Barrington James
✨Showcase Your Regulatory Expertise
Be prepared to discuss your experience with regulatory submissions in detail. Highlight specific projects where you ensured compliance and accuracy, and be ready to explain how you navigated complex regulatory frameworks.
✨Demonstrate Leadership Skills
Since this role involves leading a team, share examples of how you've successfully managed and mentored junior writers. Discuss your approach to recruitment and career progression within your teams.
✨Prepare for Strategic Discussions
Expect questions about your ability to provide strategic advice on regulatory affairs. Think of scenarios where your insights led to successful outcomes in previous roles, especially in relation to clinical trials.
✨Highlight Your Scientific Writing Proficiency
Be ready to showcase your scientific writing skills. Bring samples of your work that demonstrate clarity, precision, and adherence to regulatory standards, as well as your ability to interpret complex data effectively.