Senior Medical Writer
vor 1 Monat
Job Summary: We are seeking a highly skilled Principal Medical Writer to join our team at IQVIA. As a key member of our content development team, you will be responsible for creating high-quality clinical submission documents, including clinical study reports, protocols, and investigator brochures.
Responsibilities:
- Develop clear and concise clinical submission documents, ensuring compliance with regulatory requirements and industry standards.
- Collaborate with cross-functional teams to develop project plans, timelines, and document organization.
- Review and edit documents for consistency, grammar, and structure, ensuring key messages are clearly represented.
- Drive the document preparation process, manage timelines, and lead comment resolution meetings.
- Participate in team and client meetings, providing updates on document progress and addressing client queries.
Requirements:
- At least 8-10 years of regulatory medical writing experience in the pharmaceutical industry.
- Extensive medical writing experience, including clinical study documents and global clinical regulatory submissions.
- Strong project management skills, with ability to manage timelines and prioritize multiple projects.
- Excellent writing, interpersonal, and oral communication skills.
- Knowledge of current requirements and guidelines applicable to submission documents.
About IQVIA: We are a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Our mission is to push the boundaries of human science and data science to create a healthier world.
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