Senior Clinical Document Specialist

4 days ago


Manchester, United Kingdom Vivify Talent Full time

Vivify Talent's Mission:

We empower businesses to achieve success through effective communication and innovative solutions. As a leading medical communications agency, we're dedicated to excellence in pharmaceutical communications.

Job Summary: We're seeking an experienced European Senior Regulatory Writer to join our team, focusing on translating complex scientific and clinical data into compelling regulatory documents.

Key Responsibilities:

  • Regulatory Compliance: Ensure compliance with European regulations and industry standards, leveraging your in-depth knowledge of regulatory requirements.
  • Document Development: Develop high-quality regulatory documents, including clinical study reports, regulatory submissions, protocols, investigator brochures, and marketing authorisation applications.
  • Cross-functional Collaboration: Work collaboratively with cross-functional sponsor teams to bridge the gap between regulatory affairs and content creation.

Requirements:

  • Regulatory Expertise: Proven experience in developing regulatory documents for pharmaceutical companies, with expertise in European regulations.
  • Techincal Skills: Excellent writing, analytical, and communication skills, with the ability to distill complex information into clear, concise language.
  • Collaboration: Strong ability to work collaboratively with cross-functional teams and stakeholders.

What We Offer:

  • Competitive Salary: £60,000 - £80,000 per annum, depending on experience.
  • Benefits Package: Comprehensive benefits package, including health insurance, retirement plan, and paid time off.


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