Sci-Rec, a dynamic mid-sized Contract Research Organization (CRO) based in the United Kingdom, is currently seeking a highly experienced and motivated individual to join our team as the Head of Medical Writing and Regulatory Affairs. As a leader in the field, Sci-Rec prides itself on delivering high-quality services to biopharma sponsors across Europe. Our mission is to drive excellence in medical writing and regulatory affairs by providing strategic insights and ensuring compliance with industry guidelines.
In this role, you will be responsible for overseeing and developing a team of medical writers, ensuring the delivery of high-quality regulatory and scientific documents. Your leadership skills will be crucial as you work closely with biopharma sponsors to offer strategic insights and ensure seamless communication throughout critical projects. Additionally, you will take ownership of medical writing deliverables, ensuring compliance with regulatory requirements from organizations such as ICH, EMA, and FDA.
The ideal candidate will have proven experience in medical writing within a CRO, pharma, or biotech environment, along with strong leadership skills and expertise in regulatory writing. A deep understanding of regulatory requirements from ICH, EMA, and FDA is essential for success in this role. Excellent stakeholder management and communication skills are also key attributes we are looking for in potential candidates.
As the Head of Medical Writing and Regulatory Affairs at Sci-Rec, you will have the opportunity to shape the medical writing function autonomously while working on cutting-edge projects with innovative biopharma sponsors. This is a flexible remote-first position with occasional travel opportunities. We offer a competitive salary and benefits package to our employees.
If you are an experienced medical writing professional looking for your next challenge in a growing and collaborative CRO environment, we encourage you to apply now or reach out for a confidential discussion. This position is ideal for individuals at the senior director level who are ready to take on a high-impact role in leading a European team of medical writers. Join us at Sci-Rec and make a difference in the world of medical writing and regulatory affairs!
Seniority Level: Middle Management
Job Functions: Operations
Industries : Healthcare
