Position: Medical Writing - Oncology, Associate Director # 2090
Location: Northern NJ
Compensation: Based Upon Experience
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 qualified candidate will have proven ability to write and effectively manage the document preparation when necessary.
The Medical Writer is expected to work directly with 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 the company’s in accordance with the ICH guidelines, international regulations, the company’s standards and processes, and the Company’s Writing Style Guide as applicable. Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator Brochures, and submission documents. The writer is responsible for managing the document review process and routing documents for approval. The writer will be expected to format and manage long documents with multiple review cycles and tight deadlines.
Duties & Responsibilities:
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 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
Complies with all applicable laws / regulations of each country in which we do business
Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians
Reports legal, compliance and ethical violations in a timely manner
Bachelor's degree in life sciences
RN, Master's degree in life sciences, PharmD or PhD preferred.
8+ years’ experience writing regulatory documents in the pharma industry.
Prior experience in oncology therapeutic area is desired. Any submission writing familiarity is a plus.
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.