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. 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 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 Eisai in accordance with the ICH guidelines, international regulations, Eisai standards and processes, and the Eisai 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 a representative of the core oncology medical writing group, 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:
- 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
Process and Resource Management:
- Gives input to process improvement within and across functional areas
- Influences medical writing strategies and processes within and across functional areas
- Evaluates project status by tracking metrics, proposing corrective action and escalating issues as needed
- Assists in setting deadlines and related milestones within department
- Delegates activities to team members to focus on more complex issues and provide opportunity for employee development
- Manages the work of contractors and ensures that contractors, consultants and vendors complete assigned work according to agreed timeline
Matrix and Team Management:
- Leads by example to encourage others to prioritize personal and professional development
- Acts as a coach and mentor to staff members across units
- Participates in recruitment, selection, performance, succession, and transition activities
- Identifies team training needs and recommends solutions
- 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
- 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