Senior Director, Medical Writing

Scorpion Therapeutics; Burlington (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics in Burlington, MA is seeking a senior Medical Writing Leader to oversee a diverse team of internal and external writers. You will guide the preparation, review, and submission of clinical and regulatory documents while ensuring scientific rigor and regulatory compliance.

The role requires extensive regulatory knowledge (ICH, FDA, EMA), excellent written and verbal communication, and the ability to collaborate across clinical, regulatory, and scientific functions.

Qualifications

• Advanced degree in life sciences, medical writing, or related field (PhD, MD, or equivalent preferred).
• 15+ years of medical writing experience in biotechnology or pharmaceutical industry.
• Proven experience leading and managing medical writers.
• Extensive knowledge of regulatory requirements and guidelines (ICH, FDA, EMA).
• Excellent written and verbal communication skills.
• Strong problem-solving, strategic thinking, and ability to work in a fast-paced, collaborative environment.
• Outstanding scientific leadership, collaboration, interpersonal skills, and ability to manage team dynamics.

Responsibilities

• Lead and manage the Medical Writing team (including internal and external writers), providing guidance, mentorship, and professional development.
• Oversee the preparation, review, and submission of clinical and regulatory documents (e.g., clinical study reports, protocols, investigator brochures, regulatory submissions).
• Ensure documents are accurate, scientifically sound, and compliant with regulatory guidelines and company standards.
• Collaborate with clinical, regulatory, and scientific teams to gather and interpret data and communicate complex scientific information.
• Develop and implement medical writing processes, templates, and best practices to improve efficiency and quality.
• Stay current with industry trends, regulatory requirements, and medical writing best practices.
• Represent the Medical Writing function in cross-functional meetings and contribute to strategic planning.
• Manage timelines and resources to ensure on-time project completion.
• Other responsibilities as assigned.

Skills

Medical writing leadership

Regulatory knowledge (ICH FDA EMA)

Team management

Communication skills

Strategic thinking

Education

Advanced degree in life sciences / medical writing (PhD/MD or equivalent)

Job description

Key Responsibilities

• Lead and manage the Medical Writing team (including internal and external writers), providing guidance, mentorship, and professional development.


• Oversee the preparation, review, and submission of clinical and regulatory documents (e.g., clinical study reports, protocols, investigator brochures, regulatory submissions).


• Ensure documents are accurate, scientifically sound, and compliant with regulatory guidelines and company standards.


• Collaborate with clinical, regulatory, and scientific teams to gather and interpret data and communicate complex scientific information.


• Develop and implement medical writing processes, templates, and best practices to improve efficiency and quality.


• Stay current with industry trends, regulatory requirements, and medical writing best practices.


• Represent the Medical Writing function in cross-functional meetings and contribute to strategic planning.


• Manage timelines and resources to ensure on-time project completion.


• Other responsibilities as assigned.

Qualifications

• Advanced degree in life sciences, medical writing, or related field (PhD, MD, or equivalent preferred).


• 15+ years of medical writing experience in biotechnology or pharmaceutical industry.


• Proven experience leading and managing medical writers.


• Extensive knowledge of regulatory requirements and guidelines (e.g., ICH, FDA, EMA).


• Excellent written and verbal communication skills.


• Strong problem-solving, strategic thinking, and ability to work in a fast-paced, collaborative environment.


• Outstanding scientific leadership, collaboration, interpersonal skills, and ability to manage team dynamics.