Senior Medical Writer, Medical Writing - Lifelancer
New York, NY
About the Job
Job Title: Senior Medical Writer, Medical Writing
Job Location: New York, NY, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
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 RD 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 scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Revolution Medicines is 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. This role is an individual contributor with team leadership responsibilities, reporting into the Senior Director, Medical Writing.
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.
Please note that base salary 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 .
The Opportunity:
Revolution Medicines is 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. This role is an individual contributor with team leadership responsibilities, reporting into the Senior Director, Medical Writing.
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, 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.
- 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
- Experience with oncology therapeutics
- Familiar with PleaseReview, StartingPoint, EndNote, and Smartsheet
- Experience performing QC reviews of clinical regulatory documents
Please note that base salary 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 .
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https://lifelancer.com/jobs/view/5a06a122bd7cdbb6cc35a50b75d1615d
Source : Lifelancer