Principal Regulatory Writer - United Kingdom - Vivify Talent

Description

Job Opportunity: Principal Regulatory Writer (Remote)

About Us: We are a dynamic and growing medical communications agency committed to excellence in pharmaceutical communications. As we expand our clinical/regulatory department, we are actively seeking a talented and experienced Principal Regulatory Writer to join our team.

Role Overview: As a Principal Regulatory Writer, you will play a pivotal role in translating complex scientific and clinical data into compelling regulatory documents. Your expertise will be crucial in ensuring compliance with European regulations and industry standards.

Key Responsibilities:

• Regulatory Expertise: Leverage your in-depth knowledge of European regulations to contribute to the development of high-quality regulatory documents, including but not limited to clinical study reports, regulatory submissions, protocols, investigator brochures, and marketing authorization applications.
• Technical Mastery: Dive into the technical details of scientific and clinical data, demonstrating a keen ability to synthesize and present information accurately and coherently. Stay abreast of industry advancements and regulatory updates to ensure the highest standards of technical accuracy.
• Collaborative Engagement: Work collaboratively with cross-functional sponsor teams, bridging the gap between regulatory affairs, clinical teams, and other stakeholders. Your effective communication skills will be instrumental in fostering productive partnerships.

Flexible Working Arrangements:

• Remote Accessibility: Embrace the opportunity to work remotely, allowing you to cultivate a conducive work environment that optimizes your productivity and work-life balance.
• Full or part-time: We are happy to consider writers for either part or full-time vacancies

Qualifications and Experience:

• Bachelor's degree in a relevant scientific discipline.
• Proven experience in regulatory writing, with a focus on European regulations.
• Strong technical acumen with the ability to comprehend and articulate complex scientific and clinical information.

Benefits:

• Competitive compensation package reflective of your skills and expertise.
• Opportunity for professional growth within a thriving SME environment.
• Flexible working arrangements to accommodate your unique work style.

How to Apply: Please apply directly through this advert, reach out to Vivify Talent via our website () or on