Medical Writer - Worldwide Clinical Trials
We are seeking a skilled Medical Writer to lead the preparation of study documents for Phase I-IV clinical trials, ensuring compliance with regulatory standards across regions including the USA, Europe, and others. The role involves collaboration with various departments to develop and update documents such as protocols, amendments, informed consent forms, CTRs, Investigator Brochures, and pre-IND documents.
Key responsibilities include:
1. Leading the medical writing team in document preparation and management.
2. Ensuring documents meet regional regulatory requirements and SOPs.
3. Managing templates and serving as a publishing point-of-contact for CTRs and other documents.
Qualifications:
* University/college degree in life sciences or related field, or equivalent experience.
* Minimum of 4 years' experience as a Medical Writer or similar role.
* Excellent written and spoken English skills.
* Strong data interpretation and communication skills.
* Proficiency in Microsoft Office applications.
* Thorough knowledge of ICH guidelines (E3, E6, E9).
Additional requirements include flexibility for domestic and international travel and a passion for advancing clinical research.
Join our global team at Worldwide Clinical Trials, where innovation, diversity, and a commitment to improving lives are at the core of what we do. We offer ongoing training and career development opportunities in a collaborative environment.
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