Director, Medical Writing

Revolution Medicines•Redwood City, CA

41d•Hybrid

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Director of Medical Writing will be responsible for helping to develop strategic leadership and management of the medical writing function and involves both a people and project-orientated focus. This position reports to the Executive Director, Medical Writing.

Requirements

Doctoral degree and 5 years of regulatory medical writing experience.
Master’s degree and 7 years of regulatory medical writing experience.
Bachelor’s degree and 8 years of regulatory medical writing experience.
At least 3 years of experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Nice To Haves

Academic preparation in life sciences or pharmacy with at least 8 years of related experience in the pharmaceutical/biotechnology industry.
Experience in oncology.
Strong understanding of drug development process.
Experience with authoring major clinical regulatory documents, including protocols and amendments, study reports, and marketing application summaries.
Experience with structured content management and/or generative AI use in the medical writing space preferred but not required.

Responsibilities

Driving for success in terms of people, projects, and productivity of medical writing, including all deliverables in alignment with corporate goals.
Assuring the successful completion of high quality, timely and compliant document deliverables.
Developing and implementing remediation plans/actions as needed.
Providing medical writing leadership and guidance to full-time and contract medical writers.
Assisting the Executive Director, Medical Writing, in developing budget and resource requirements for contract medical writers across multiple programs for each fiscal year.
Demonstrating current and applied knowledge and understanding of regulatory requirements and standards to ensure consistent application, adherence, and timely achievement of compliant deliverables.
Serving as a primary subject matter expert for the planning, design, and preparation of clinical and regulatory documents.
Authoring and reviewing clinical regulatory documents as needed, including assisting teams in responding to regulatory requests.
Attracting, hiring, and retaining qualified contract medical writing professionals
Providing an atmosphere of training, mentorship, and coaching to align with a strategic view of the role of medical writing in clinical development.
Working within the medical writing function and cross-functionally to test and develop policies regarding the use of structure content management and/or generative AI as part of clinical regulatory document processes.
Structuring resourcing to ensure an effective and cost-efficient approach to covering portfolio workload and goals while ensuring sustainability and alignment with corporate goals.
Providing leadership across the medical writing department through strategic input, continual process improvement, and innovation in the development and implementation of a strategic view of regulatory documents.
Collaborating and partnering with cross functional leaders and other staff across project management, regulatory affairs, clinical operations, clinical development, biostatistics, and other functions.
Representing the medical writing department externally with academic institutions, industry groups/peers, vendors and other entities to develop expertise and drive industry standards and best practice.