Senior Medical Writer

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.PositionWe are seeking an experienced, detail-oriented individual to work with our Medical Writing team. In the Senior Medical Writer role, you will be responsible for independent lead authoring and editing of medical and regulatory writing deliverables that support the clinical portfolio. You will partner with colleagues within Medical Writing as well as with the Nonclinical, Clinical, & Regulatory teams to prepare high-quality, accurate and concise documentation supporting the objectives of both teams and leadership. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California, New York, or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About YouYou are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing.What You'll DoIndependently author regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules, briefing documents, and other nonclinical or clinical documents per company and regulatory guidelines.Contribute to document development as an independent lead author and as part of a larger terpret data and apply knowledge of regulatory/compliance/scientific requirements to document manage document lifecycle, including timeline management, review cycle management, and document quality management where to iteratively improve medical writing processes as to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master's degree with 3+ years of relevant experience, or Bachelor's degree with 5+ years of relevant experience in regulatory, scientific, or medical writing.Demonstrated scientific or medical writing acumen.Demonstrated excellent presentation, communication, and project management skills.Ability to independently prepare nonclinical or clinical regulatory documents (e.g., protocol, CSR, IB, CTD modules) according to company guidelines and international governmental regulations, focused on presenting data objectively, in a clear, concise format in keeping with industry guidelines.Ability to interpret scientific and clinical data and adapt to varying audiences, including figure or table generation for clear data representation where track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.Keen interest in staying up to date with respect to regulatory guidance and modern medical writing practices.Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products. Working knowledge of statistical concepts and techniques.Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote). Familiarity with concepts of structured content management preferred.Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a collaborative and innovative team.At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:401k plan with company matchingMedical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)Mental health and wellness benefitsWeeklong summer and winter holiday shutdownsGenerous paid time off and holiday policiesLife/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefitDaily subsidized lunch program when on-siteThe expected salary range for this role is $125,000 to $136,800 depending on skills, competency, and the market demand for your expertise.Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

Created: 2024-11-12