Director, Medical Writing

Position 

As the Functional Head, Director, Medical Writing, you will hold a strategic leadership role in the translation of complex scientific and medical information into clear and concise written materials. Operating in a dynamic and collaborative environment, you will lead a team of medical writers and contribute significantly to the development of various documents that support our research, clinical trials, and regulatory activities.

This role will require a minimum of 3 days a week onsite presence (or more as business needs require) in either of our Jersey City (NJ), New York City (NY) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant growth & collaboration.

About You 

The ideal candidate for this role should possess strong writing and communication skills to effectively convey complex scientific concepts in a clear and concise manner. Exceptional attention to detail and a commitment to producing accurate and high-quality written materials are essential, as well as proficiency in the Microsoft Office Suite and familiarity with scientific writing tools. The candidate should excel in a fast-paced and collaborative work environment and be capable of leading a medical writing team, fostering their growth and development. While knowledge of clinical research, regulatory requirements, and biotechnology is advantageous, it is not a strict requirement. Effective collaboration with cross-functional teams and leadership in aligning written materials with project goals and timelines are key attributes for this position.

What You’ll Do 

•    Team Leadership: Provide guidance, mentorship, and leadership to the internal medical writing team, fostering their professional growth and development.
•    Document Leadership: Oversee and lead the creation of a wide range of medical and scientific documents, including clinical study protocols, investigator brochures, regulatory submissions, and scientific publications.
•    Content Development: Collaborate closely with cross-functional teams to collect, interpret, and synthesize data, ensuring accuracy and relevance in written materials.
•    Regulatory Compliance: Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards.
•    Literature Review: Conduct comprehensive literature reviews to support the development of evidence-based documents.
•    Data Interpretation: Proficiently interpret and summarize complex scientific data and clinical trial results for various audiences.
•    Editing and Proofreading: Review and edit documents for grammar, clarity, and consistency while maintaining a high level of accuracy.
•    Strategic Planning: Contribute to the strategic planning and execution of medical writing projects to support research and development initiatives.
•    Cross-functional Collaboration: Collaborate closely with scientists, clinical teams, and regulatory affairs professionals to align written materials with project goals and timelines.

Qualifications

•    Post Graduate degree with 10+ years of experience or a Bachelor's degree with 12+ years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline).
•    Strong writing and communication skills, with the ability to effectively convey complex scientific concepts in a clear and concise manner.
•    Exceptional attention to detail and commitment to producing accurate and high-quality written materials.
•    Proficiency in Microsoft Office Suite and familiarity with scientific writing tools.
•    Capability to thrive in a fast-paced and collaborative work environment.
•    Demonstrated experience with regulatory submissions (IND, NDA) and a deep understanding of regulatory requirements and guidelines (FDA, EMA, ICH).
•    Proven track record of managing teams, mentoring writers, and working collaboratively with cross-functional teams.

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 $204,000 to $223,250 depending on skills, competency, and the market demand for your expertise.