Medical Writer Specialist, Clinical Regulatory Documents

5 days ago

New York, New York, United States Lifelancer Full time
Overview

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.


Compensation and Benefits

The estimated salary for this full-time position is $145,000 to $180,000 per year, based on the title, job description, and location. This includes a competitive cash compensation package, robust equity awards, strong benefits, and significant learning and development opportunities.


Job Description

We are seeking a motivated individual with a clinical regulatory writing background to play a critical role in the successful preparation of high-quality, submission-ready clinical research documents. As a medical writer specialist, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

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.


Key Responsibilities
  • Serves as medical writing lead on complex clinical regulatory documents, including protocols, IBs, CSRs, briefing documents, and IND and NDA modules.
  • Manages multiple and overlapping document timelines in a dynamic environment.
  • Effectively communicates deliverables needed, the writing process, and timelines to team members.
  • Schedules document reviews in PleaseReview and manages adjudication meetings.
  • Holds team members accountable to agreed-upon project dates.
  • Independently resolves document content issues and questions.
  • Ensures consistency, clarity, and accuracy both within and across documents.
  • Recognizes potential scheduling and resource conflicts across projects and provides recommendations to resolve.
  • Assists the Senior Director, Medical Writing, and mentors junior and contract medical writers, as needed.

Required Skills and Qualifications
  • 5+ years of clinical regulatory writing experience within a biopharmaceutical company.
  • Advanced degree in clinical or life sciences, English, journalism, and/or communications.
  • Proficient in Microsoft Word.
  • Familiar with AMA style.
  • Detail-oriented, compelled to check for errors in spelling, punctuation, grammar, and formatting.
  • Able to successfully manage and prioritize writing projects with competing deadlines.
  • Able to foster strong collaborative relationships with clinical development team members to ensure timely completion of high quality submissions and compliance with regulatory processes and standards.
  • Outstanding interpersonal and communication skills: able to work with multiple groups of people at one time, remaining calm, professional, diplomatic, and positive.

Becoming Part of the Team

As an equal opportunity employer, Revolution Medicines 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. We are committed to creating an inclusive work environment that values diversity and promotes equality.

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