Reference Number: JO-1909-437549
Associate Director – Medical Writing
Job Type: Permanent
Location: United States
CPL Physicians is working with a world leading oncology research business based near New York City who are looking for an Associate Director – Medical Writing.
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. 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
Works across functional areas to obtain all applicable source material
Interacts routinely with clinical research, programming and biostatistics staff to gain comprehensive understanding of the study design, objectives, and results
Serves as a medical writing subject matter expert (SME) for other functional areas
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
Leads by example to encourage others to prioritize personal and professional development
Acts as a coach and mentor to staff members across units
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
For more information on this key role please CLICK APPLY and forward an up to date resume.