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About Us:We are a dynamic and growing medical communications agency committed to excellence in pharmaceutical communications. As we expand our regulatory department, we are actively seeking a talented and experienced European Senior Regulatory Writer to join our team.
Role Overview:As a Senior Regulatory Writer, you will play a key 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.
Fully remote, home based.
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 authorisation applications. Extensive training is offered for documents you do not currently have experience in.
- Technical Excellence: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 working
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 (vivifytalent.com) or on +44 (0) 1223 080 457
