Medical Writer 2 Jobs

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 disease. 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 of proteins as drug targets.
Position
We are seeking an experienced, detail-oriented Medical Writer II to work with our Medical Writing team in New York, NY or Hayward, CA. 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.
About You
You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing.
What You’ll Do

• Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations.
• Contribute to document development as an independent lead author and as part of a larger team.
• Independently manage document lifecycle, including timeline management, review cycle management, and document quality management where appropriate.
• Independently author regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules, and other nonclinical or clinical documents per company and regulatory guidelines.
• Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
• Help to iteratively improve medical writing processes as appropriate.

Qualifications

• Bachelor’s degree in Life Sciences with 10+ years, Master’s degree with 6+ years, or doctoral-level degree (e.g., Ph.D., M.D., PharmD) with 0-1 years of experience in regulatory, scientific, or medical writing.
• 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.
• Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a collaborative and innovative team.
• Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., Google Docs, SharePoint, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote). Familiarity with concepts of structured content management preferred.
• Demonstrated excellent presentation, communication, and project management skills.
• Demonstrated scientific or medical writing acumen.
• 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 appropriate.
• Proven 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.

The expected hourly range for this role is $62-$71 per hour depending on skills, competency, and the market demand for your expertise.