Global Medical Writing Lead – Regulatory Strategy & Mentorship

Millipore Corporation; Billerica (MA); Hybrid; USD 127,000 - 215,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

EMD Serono is seeking a Principal Medical Writer to lead end-to-end development of regulatory clinical study documents, ensuring scientific rigor and regulatory compliance globally and regionally. You will mentor writers, oversee CTD-style documents, and coordinate with cross-functional teams to meet timelines.

The role is hybrid with onsite requirements in Billerica, MA, and offers opportunities to influence best practices in medical writing across multiple markets.

Qualifications

• Bachelor's degree required in a scientific or writing discipline; advanced degree preferred.
• 5–8 years of medical writing experience with regulatory documentation background.
• Experience leading and coordinating local/global teams in a matrix organization; vendor management is a plus.

Responsibilities

• Lead global and regional clinical study documents (protocols, CSRs, authority responses).
• Represent Medical Writing in study teams; participate in governance and meetings.
• Oversee document reviews and coordinate with cross-functional teams to ensure regulatory compliance.

Skills

Medical writing

Regulatory documents

Project management

Communication

Education

Bachelor's degree in science or writing

Tools

MS Office

SharePoint

Electronic document mgmt systems

Job description

EMD Serono is seeking a Principal Medical Writer to lead end-to-end development of regulatory clinical study documents, ensuring scientific rigor and regulatory compliance globally and regionally. You will mentor writers, oversee CTD-style documents, and coordinate with cross-functional teams to meet timelines.

The role is hybrid with onsite requirements in Billerica, MA, and offers opportunities to influence best practices in medical writing across multiple markets.