Director, Medical Writer

Job Description

Position Summary

The Director, Medical Writing will be an integral position working with the Clinical Development function to facilitate the translation of complex scientific and medical information into clear and concise written materials. Operating in a dynamic and collaborative environment, the incumbent will lead the development of various documents that support our clinical trials, research/publications and regulatory activities.

This role requires strong writing and communication skills to effectively convey complex clinical and scientific concepts in a clear and concise manner. Attention to detail and a commitment to producing accurate and high-quality written materials are essential. Proficiency with Microsoft Office Suite and familiarity with scientific writing tools are required. Knowledge of clinical research, regulatory requirements, and biotechnology are desired. Candidates need to be comfortable in a fast-paced and collaborative work environment and able to work effectively with cross-functional teams.

Job Responsibilities

• Lead and execute on the creation of a wide range of medical and scientific documents, including briefing books, clinical study protocols, investigator brochures, regulatory submissions, and scientific publications.
• Collaborate closely with cross-functional teams to collect, interpret, and synthesize data, ensuring accuracy and relevance in written materials.
• Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards.
• Conduct comprehensive literature reviews to support the development of evidence-based documents.
• Proficiently interpret and summarize complex scientific data and clinical trial results for various audiences.
• Review and edit documents for grammar, clarity, and consistency while maintaining a high level of accuracy.
• Contribute to the strategic planning and execution of medical writing projects to support research and development initiatives.
• Collaborate closely with scientists, clinical teams, and regulatory affairs professionals to align written materials with project goals and timelines.

Education and Experiences

• 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).
• Proficiency in Microsoft Office Suite and familiarity with scientific writing tools.
• Demonstrated experience with regulatory submissions (IND, NDA) and a deep understanding of regulatory requirements and guidelines (FDA, EMA, ICH).
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research

Technical Skills/Core Competencies

• Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally
• 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.
• Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points
• Comfortable working in fast paced entrepreneurial environment
• Ability to travel up to 20%

Salary Range: $170,000-185,000