Medical Writer, Medical Writing

Revolution Medicines

2+ years

Not Disclosed

Remote, USA

10 May 27, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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 scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

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.

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 clinical regulatory documents, including protocols, IBs, ICFs, DSURs, CSRs, 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.
Required Experience, Skills, and Education:
2+ years of clinical regulatory writing experience within a biopharmaceutical company
Degree in clinical or life sciences, English, journalism, and/or communications
Proficient in Microsoft Word
Familiar with AMA style
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, as needed.
Detail-oriented, compelled to check for errors in spelling, punctuation, grammar, and formatting
Able to successfully manage and prioritize writing projects with competing deadlines
Preferred Skills, Experience, and Education:
Experience with oncology therapeutics
Familiar with PleaseReview, StartingPoint, EndNote, and Smartsheet
Able to quickly amend a protocol or other document in response to a health authority request
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 generating or using model documents
Experience performing QC reviews of clinical regulatory documents
The expected salary range for this role is $120,000 to $158,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary is one part of the overall total rewards program at Revolution Medicines, 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

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Medical Writer, Medical Writing

Job Description

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