3 months ago
Hamlyn Williams are working on an exciting role with a client in New Jersey who require an Associate Director for multiple oncology programs.
The candidate responsible for supporting the critical regulatory medical writing needs, and offering direction to other staff/contractors regarding these projects. As the lead writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the compound to ensure alignment and consistency across studies.
The Medical Writer will work directly with the project and clinical study teams, the oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents. The candidate should be able to prepare regulatory documents in accordance with the ICH guidelines, international regulations and the Writing Style Guide as applicable.
Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Brochures, and submission documents. The writer is responsible for managing the document review and approval process. The writer will be expected to manage the completion of complex documents with multiple review cycles and tight deadlines.
The Associate Director will act as a liaison between the project/study team and the OBG Medical Writing group.
Responsibilities include but are not limited to:
Job Qualifications :
- Experience in writing clinical study protocols, CSRs, and Module 2 clinical summaries
- Prior experience in oncology therapeutic area is desired
- Excellent writing skills
- Meticulous attention to detail
- Proficiency using an electronic document management system
- Strong analytical ability to interpret clinical data
- The medical writer should be familiar with ICH guidelines and the current AMA Style Manual
This client is actively considering applications so please send your CV to firstname.lastname@example.org or for more information please call +1(347) 242 5722