About the Role >>> Lead Senior Medical Writer
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.ย
This roleย isย based out of ourย Boston, MA or San Francisco, CAย office and will requireย 10-15%ย travel.ย
Your work willย primarilyย encompass:ย
- Preparing and editing a wide range of scientific and medical writing deliverables, including but not limitedtoprotocols, protocol amendments,clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs,DSURs,sections of IND/IMPD/MAAs),PowerPoint presentationsrelated to the Medical Writing function
- Collaborating with internal stakeholders (clinical scientists, regulatory strategy,medical monitors, biometrics,medical affairs) to understand data, interpret results, and ensureaccuratemessage conveyance
- Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), andappropriate therapeutic-areastandards (e.g., oncology, breast cancer)
- Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
- Providing writingand/orQCeditingsupport forassociated 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
Idealย Candidate Profile >>>ย ย
A love of challenging, important work.ย We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. Allย employeesย within our company play aย unique andย crucial roleย in our success, both inย accomplishingย our mission and buildingย a positiveย company culture. As such, we are looking forย someone withย the right combination ofย knowledge,ย experience, andย attributesย for this role.ย
Knowledge:ย
- Bachelor's degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
- Demonstrated and excellent scientific writing and editing skills -ย the abilityย to translate complexย scientific data into clear,ย concise,accuratedocuments for varied audiences (regulatory agencies, KOLs, internal stakeholders)
- Familiarity withregulatory writingstandards (e.g., ICH E3/E6,ย GPP)
- Oncology preferredย
- Veeva RIM experienceย is a plusย
Experience:ย
- Minimum ofย 7+ย years of medical or regulatory writing experience, oncology (especially breast cancer)ย preferred, orย a closely related therapeutic area
- Strongproject managementskills: able tomanagemultiple 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
- Proficiencywith standardtechnicaland document-management tools (e.g., Microsoft Word, PowerPoint,Microsoft Excel, Smartsheet,Starting Point Templates, Veeva RIM)
- Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols,DSURandCSRs) preferred
- Experience working in hybrid/remote environments
Attributes:ย
- Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
- Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization
- Strong communicator who can tailor messaging to diverse audiences
- Highly organized with strong attention to detail and follow-through
- Ability in building strong cross functional working relationshipsย
The base pay range for this position is expected to beย $160,000-$175,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
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