Immunome, Inc. · 2 months ago
Senior Manager, Medical Writing
Bothell, Washington, United States
Full-time
Onsite
Senior Level
$169K/yr - $203K/yr
6+ years expImmunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. The Senior Manager, Medical Writing will be responsible for authoring and leading the creation of high-quality medical and scientific documents that support the development, regulatory approval, and commercialization of products, collaborating with various internal groups to ensure timely and compliant deliverables.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
Author and/or manage the preparation of medical writing deliverables such as clinical study protocols, CSRs, IBs, eCTD written/tabular summaries, clinical overviews, briefing packages, Module 2 summaries, and IND enabling documents
Develop submission strategies in collaboration with stakeholders and ensure document preparation, review, and approval follow prescribed processes and conform with appropriate regulatory guidance (i.e., GCP, ICH guidelines, and eCTD requirements)
Ensure timely and successful responses to health authority questions and/or requests
Authoring of ICF and other patient facing materials
In collaboration with stakeholders, facilitate the redaction of clinical study protocols and other documents that fall within the scope of the implementation of EU-CTR
Author and/or manage the preparation of manuscripts, abstracts, and posters for medical and scientific conferences and journals
Collaborate with subject matter experts and external authors to develop high-quality publications
Ensure publications align with strategic communication plans and company objectives
In collaboration with internal partners, develop and implement suitable document templates, style standards, and quality control checklists to ensure consistent and high-quality deliverables
Ensure the development and maintenance of relevant SOPs and internal best practices
In collaboration with the Head of Medical Writing, evaluate and drive adoption of innovative approaches medical writing and communication strategies that may assist in document development, review, and/or QC
Qualification
Required
Advanced degree (PhD, PharmD, MD) in a scientific discipline or related field preferred. Other relevant experience will also be considered
A minimum of 6 years of experience in medical writing and scientific communications within the pharmaceutical or biotechnology industry; oncology experience a plus
Knowledge of regulatory requirements and guidelines (e.g., ICH, GCP, FDA, EMA, AMA style guide)
Excellent writing, editing, and verbal communication skills
Strong project management skills with the ability to manage multiple projects simultaneously
Proficiency with medical writing software and tools
Exceptional attention to detail and a commitment to excellence
Strong business acumen and a deep knowledge and understanding of the drug development process
Experience managing vendors and contractors a plus
Strategic thinker with strong analytical skills and ability to work in a fast-paced environment
Collaborative and able to build effective working relationships across the organization and with external stakeholders and collaborators
Strong ethical standards and integrity
Company
Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$998.85MKey Investors
JPEO-CBRNDU.S. Department of DefenseRobin Hood Ventures
2025-12-16Post Ipo Equity· $400M
2025-01-29Post Ipo Equity· $150M
2024-02-13Post Ipo Equity· $230M
Leadership Team
Clay Siegall
President and CEO
Purnanand D. Sarma
President & CEO
Recent News
2026-01-09
BioWorld Financial Watch
2025-12-19
Company data provided by crunchbase