The ideal candidate will be the designated Lead Medical Writer for one or more oncology programs, 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.
The Medical Writer is expected to 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 incumbent should be able to prepare regulatory documents on behalf of Company in accordance with the ICH guidelines, international regulations, Company standards and processes, and the Company Writing Style Guide as applicable.
Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator's 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.
• As the compound lead, independently prepares, and at times directs the writing of PCSs, protocols and protocol amendments
• As the compound lead, independently prepares, and at times directs the writing, all sections of the CSRs
• Leads the preparation of clinical sections of submission documents, such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reports
•Leads the writing activities for marketing application submission documents
• Liaises with other functional areas and groups in the development of document standards and structure
•Implements document quality controls, standards and best practices
•Bachelor's degree in life sciences
•RN, Master's degree in life sciences, PharmD or PhD preferred.
•8+ years of experience writing clinical and regulatory documents in the pharmaceutical industry.
•Experience in writing clinical study protocols, CSRs, and Module 2 clinical summaries
•Prior experience in oncology therapeutic area is desired
•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
Source: Job Diva – Job Listing