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6 days
Not Specified
Not Specified
$32.81/hr - $56.35/hr (Estimated)
<p>Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential. </p> <p>Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you're ready to join us at the edge of something unstoppable, let's make a profound impact together for our patients, for your career, for what's beyond. </p> <p>You can view our latest corporate deck and other presentations here.</p> <p>About the Role >>> Lead Senior Medical Writer</p> <p>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. </p> <p>This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel. </p> <p>Your work will primarily encompass: </p> <ul> <li>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 </li><li>Collaborating with internal stakeholders (clinical scientists, regulatory strategy,?medical monitors, biometrics,?medical affairs) to understand data, interpret results, and ensure?accurate?message conveyance </li><li>Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and?appropriate therapeutic-area?standards (e.g., oncology, breast cancer) </li><li>Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines </li><li>Providing ?writing?and/or?QC?editing?support for?associated submission documents?(as applicable) to help elevate overall team deliverables </li><li>Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women's cancers </li></ul> <p>Ideal Candidate Profile >>> </p> <p>A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. </p> <p>Knowledge: </p> <ul> <li>Bachelor's degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred </li><li>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) </li><li>Familiarity with?regulatory writing?standards (e.g., ICH E3/E6, GPP) </li><li>Oncology preferred </li><li>Veeva RIM experience is a plus </li></ul> <p>Experience: </p> <ul> <li>Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer) preferred, or a closely related therapeutic area </li><li>Strong?project management?skills: able to?manage?multiple deliverables, meet deadlines, handle feedback iterations, and coordinate with cross-functional teams </li><li>Ability to work independently with minimal supervision, while also being a collaborative team player </li><li>Detail-oriented, organized, with strong verbal communication skills </li><li>Proficiency?with standard?technical?and document-management tools (e.g., Microsoft Word, PowerPoint,?Microsoft Excel, Smartsheet,?Starting Point Templates, Veeva RIM) </li><li>Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols,?DSUR?and?CSRs) preferred </li><li>Experience working in hybrid/remote environments </li></ul> <p>Attributes: </p> <ul> <li>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 </li><li>Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization </li><li>Strong communicator who can tailor messaging to diverse audiences </li><li>Highly organized with strong attention to detail and follow-through </li><li>Ability in building strong cross functional working relationships </li></ul> <p>The base pay range for this position is expected to be $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.</p> <p>#LT-MT1</p> <p>Important Information >>></p> <p>We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.</p> <p>We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.</p> <p>Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.</p> <p>Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema's official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.</p>
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