Lead Senior Medical Writer

Olema Oncology • Boston, MA

18h • $160,000 - $175,000 • Hybrid

About The Position

As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific and regulatory documents supporting Olema’s oncology portfolio. This role requires strong cross-functional leadership, partnering closely with Clinical Science, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to translate complex clinical and preclinical data into clear, accurate, and compelling content for regulatory submissions, medical communications, and scientific publications. In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones.
This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel.

Requirements

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
• Demonstrated and excellent scientific writing and editing skills — the ability to translate complex scientific data into clear, concise, accurate documents for varied audiences (regulatory agencies, KOLs, internal stakeholders)
• Familiarity with regulatory writing standards (e.g., ICH E3/E6, GPP)
• Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer) preferred, or a closely related therapeutic area
• Strong project management skills: able to manage multiple deliverables, meet deadlines, handle feedback iterations, and coordinate with cross-functional teams
• Ability to work independently with minimal supervision, while also being a collaborative team player
• Detail-oriented, organized, with strong verbal communication skills
• Proficiency with standard technical and document-management tools (e.g., Microsoft Word, PowerPoint, Microsoft Excel, Smartsheet, Starting Point Templates, Veeva RIM)
• Experience working in hybrid/remote environments

Nice To Haves

• Oncology preferred
• Veeva RIM experience is a plus
• Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols, DSUR and CSRs) preferred

Responsibilities

• Preparing and editing a wide range of scientific and medical writing deliverables, including but not limited to protocols, protocol amendments, clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs, DSURs, sections of IND/IMPD/MAAs), PowerPoint presentations related to the Medical Writing function
• Collaborating with internal stakeholders (clinical scientists, regulatory strategy, medical monitors, biometrics, medical affairs) to understand data, interpret results, and ensure accurate message conveyance
• Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and appropriate therapeutic-area standards (e.g., oncology, breast cancer)
• Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
• Providing writing and/or QC editing support for associated submission documents (as applicable) to help elevate overall team deliverables
• Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women’s cancers

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees