Assoc Dir Medical Writing

About Daiichi Sankyo Cancer Enterprise
The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary:
The primary responsibilities of this position are to establish strategies for document authoring, contribute strategically and scientifically at the project and/or study team level, manage CROs and external writers with regard to document quality, and develop medical writing timelines, processes, and working standards. The position can independently serve as primary author of complex clinical documents (e.g., pivotal Phase 3 protocols and reports) and be a lead writer for NDA/MAA submission documents. This position has advanced knowledge of NDA/MAA submissions, knowledge of document management systems, knowledge relevant therapeutic areas, and knowledge of other aspects of drug development (e.g., nonclinical, pharmacokinetics, biostatistics).

Responsibilities:

• Establishes strategy for document authoring; Determines resource needs, proactively identifies issues and solutions, and sets timelines and processes
• Writes critical, complex clinical documents (e.g., pivotal Phase 3 protocols and reports, NDA/MAA submission documents) with minimal input from functional area experts; Ensures key messages are clear and consistent within and across documents; Able to independently search scientific literature to place study results in context with other relevant data
• Contributes strategically and scientifically at the project and/or study team level; Contributes to formation of key messages in consultation with functional area experts (e.g. Recommending data outputs for collection of specific data, proposing document strategy for filings or responding to health authority requests); Advises project and study teams regarding regulatory requirements and ICH guidance for clinical documents
• Manages CROs and external writers with regard to document quality; Provides guidance to CROs and external writers on company standards and style and industry best practices for medical writing
• Develops medical writing timelines, processes, and working standards; Ensures company SOPs, templates, style guides, etc, are aligned with industry best practices
• Manages other MWs, assess performance and perform mid and end of year appraisals

Qualifications:

• Minimum 5-7 years of experience with a Master's of Science degree or PhD or
• Minimum 7+ years of experience with a Bachelor's degree
• Regulatory Medical writing experience required
• Submission document experience required

Job Title
Assoc Dir Medical Writing

City
Basking Ridge

Functional Area
Regulatory Management Operations

State
New Jersey