Associate Director, Medical Writing

Position

We 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 Jersey City (NJ), New York (NY), or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. 

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

• Independently 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 team.
• Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
• Independently manage document lifecycle, including timeline management, review cycle management, and document quality management where appropriate.
• Help to iteratively improve medical writing processes as appropriate.
• Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations.

Qualifications

• 10+ Years of experience with a Bachelor's degree, or 8+ years of experience with a post graduate degree.
• 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 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.
• 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 matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $174,000 to $190,000 depending on skills, competency, and the market demand for your expertise.