Manager - Regulatory Medical Writing

Roles & Responsibilities
• Write and review regulatory medical writing documents such as protocols, clinical study reports (CSRs), narratives, informed consent documents (ICDs), and clinical overviews and summaries
• Develop slide decks and website content related to regulatory writing
• Support primary clinical manuscripts, literature reviews, abstracts, posters, and other related materials
• Collaborate with cross-functional teams to ensure accuracy and compliance with regulatory guidelines
• Ensure timely delivery of high-quality medical writing content

Qualification
• Degree or Postgraduate in Life Sciences

Experience
• 10+ years in Regulatory Medical Writing

Skills
• In-depth knowledge of regulatory writing processes and requirements
• Strong writing and editing skills with attention to detail
• Experience with clinical documentation and submission processes
• Ability to work collaboratively within cross-functional teams
• Proficient in scientific writing and document preparation

About The Company
Krystelis Ltd is a leading organization specializing in regulatory medical writing services. With a focus on compliance and quality, Krystelis works on diverse clinical and regulatory writing projects, helping clients navigate the complexities of medical documentation.