Principal Medical Writer at Revolution Medicines

, , United States -

Full Time

Start Date

Immediate

Expiry Date

08 Jun, 26

Salary

251000.0

Posted On

10 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Drafting, Managing Content, Clinical Regulatory Documents, Protocols, IBs, CSRs, Briefing Documents, Periodic Safety Reports, Risk Management Documents, IND Modules, NDA Modules, Document Templates, Standard Processes, Onboarding Materials, Style Guide, Mentoring

Industry

Hospitals and Health Care

Description

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: This position is responsible for drafting and managing the content and reviews of clinical regulatory documents for Revolution Medicines products in various drug development phases. Serves as medical writing lead on complex clinical regulatory documents, including protocols, IBs, CSRs, briefing documents, periodic safety reports, risk management documents, and IND and NDA modules. Assists in developing and maintaining document templates, department standard processes and work instructions, medical writer onboarding materials, and style guide. Serves as primary medical writing contact for one or more clinical development programs. Represents medical writing at cross-functional planning meetings. Effectively communicates deliverables needed, the writing process, and timelines to team members. Schedules document reviews and manage adjudication meetings. Holds team members accountable to agreed-upon project dates. Independently resolves document content issues and questions. Ensure consistency, clarity, and accuracy both within and across documents. Recognizes potential scheduling and resource conflicts across projects and provides recommendations to resolve. Mentors junior and contract medical writers on both document and timeline management. Required Skills, Experience and Education: 8+ years of clinical regulatory writing experience within one or more biopharmaceutical companies, including prior experience working as a medical writer for a BLA/NDA/MAA. Advanced degree in clinical or life sciences, English, journalism, and/or communications. Proficiency in Microsoft Word, including the use of MS Word styles and templates. Familiarity with AMA style. Ability to successfully manage and prioritize writing projects with competing deadlines, to foster collaborative cross-functional relationships, and to drive high-quality regulatory writing projects to successful submission. Ability to work in a high-pressure environment with short deadlines while remaining calm, focused, professional, diplomatic, and positive. Preferred Skills: Experience with oncology therapeutics. Familiarity with StartingPoint, EndNote, Veeva RIM, and Smartsheet. Experience performing QC reviews of clinical regulatory documents. #LI-Hybrid #LI-JC1 The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. Base Pay Salary Range $201,000—$251,000 USD We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address. If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.

Responsibilities

This role is responsible for drafting and managing the content and reviews of clinical regulatory documents across various drug development phases, serving as the medical writing lead for complex documents like protocols, IBs, and CSRs. The individual will also assist in developing department standards, act as the primary contact for clinical programs, and mentor junior writers.