PAREXEL
Job Summary:
Join our dynamic team as a Lead Medical Writer, where you'll play a crucial role in crafting, reviewing, and finalizing clinical research documents that meet regulatory standards. In this position, you will be the primary client liaison for medical writing projects, collaborating with various departments to ensure timelines are met while providing leadership and mentorship to junior writers.
Key Responsibilities:
- Document Creation: Collect, evaluate, and synthesize relevant information to develop high-quality clinical documents for regulatory submissions, including investigator brochures, study protocols, and clinical study reports.
- Quality Assurance: Ensure accuracy, consistency, and compliance with FDA/EMA guidelines and internal SOPs while preparing documents for publication.
- Project Management: Lead medical writing projects by coordinating with team members, managing timelines, and addressing project-related challenges proactively.
- Collaboration: Work closely with project teams to gather insights, facilitate meetings, and drive document development towards successful completion.
- Training and Development: Mentor and train junior writers, helping them grow their skills and ensure high standards within the department.
Skills:
- Superior interpersonal and communication skills.
- Strong attention to detail and a proactive mindset.
- Excellent organizational abilities with the capability to manage multiple projects simultaneously.
- Ability to adapt to changing priorities and work efficiently in a matrix environment.
- Demonstrated experience in negotiating project needs effectively while maintaining strong client relationships.
Knowledge and Experience:
- Thorough understanding of clinical research, drug development processes, and relevant regulations.
- Proven experience in scientific writing with a strong portfolio of clinical documents.
- Advanced proficiency in MS Office, particularly Word, as well as familiarity with document management and collaborative authoring tools.
- Fluency in English, with excellent writing and editing skills.
- A scientific background in Life Sciences or Health-related fields is essential.
Education:
- Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
Join us in striving for excellence in clinical documentation and make a meaningful impact on our projects and clients!