Director, Regulatory Tech & Medical Writing Systems

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 187,000 - 254,000; Full time

Benefits offered by this job

Medical benefits

401(k) matching

Paid time off

Job summary

Alnylam Pharmaceuticals seeks a Director, Regulatory Technology & Medical Writing Systems to shape the technology strategy for Regulatory Affairs, Regulatory Operations, and Medical Writing. You will lead as the primary business technology functional leader, ensuring platforms, data, and workflows enable compliant, inspection-ready operations across the product lifecycle.

The role requires experience shaping strategy with cross-functional partners (Technology, Data, Quality, Security) and

Qualifications

• Degree in IT/CS/Data Science or related field.
• Proven business analysis and project management skills.
• Experience shaping technology strategy in regulated life sciences.

Responsibilities

• Provide technology leadership for Regulatory Affairs, Regulatory Operations, and Medical Writing.
• Define and maintain the technology roadmap and platform investments.
• Oversee regulatory information management, submission planning, and publishing workflows.
• Lead governance, data privacy, validation, and inspection readiness practices.
• Collaborate with cross-functional partners to ensure integrated, scalable solutions.

Skills

Business analysis

Project management

Regulatory systems knowledge

Leadership

Education

Degree in Information Technology / Computer Science / Data Science

Tools

Veeva Regulatory

RIM

Document management

Workflow automation

Job description

Alnylam Pharmaceuticals seeks a Director, Regulatory Technology & Medical Writing Systems to shape the technology strategy for Regulatory Affairs, Regulatory Operations, and Medical Writing. You will lead as the primary business technology functional leader, ensuring platforms, data, and workflows enable compliant, inspection-ready operations across the product lifecycle.

The role requires experience shaping strategy with cross-functional partners (Technology, Data, Quality, Security) and