Senior Director, Regulatory Writing & Strategy

Eli Lilly and Company; Boston (MA); Remote; USD 100,000 - 147,000; Full time

Benefits offered by this job

Remote work across US

Job summary

Eli Lilly and Company in a multi-location setup seeks a Senior Director to lead the regulatory and medical writing function within ExploR&D, overseeing document development and IT tool support across clinical and regulatory programs.

The role requires strategic leadership, vendor and process management, and deep regulatory knowledge to support regulatory interactions and external collaborations across global trials.

Qualifications

• At least 7 years’ of experience in the pharmaceutical industry in two or more areas: preclinical development, clinical development, regulatory affairs, regulatory writing.
• Mastery of written English with at least 3 years’ experience in writing regulatory, clinical trial documents, and/or scientific publications.

Responsibilities

• Lead cross-functional teams to ensure timely development of writing deliverables for ExploR&D portfolio.
• Plan, write, edit, review, and coordinate complex regulatory documents and publications.
• Oversee quality review and finalization of documents and manage document management systems.

Education

Advanced graduate degree (PharmD, PhD, MD)

Job description

Eli Lilly and Company in a multi-location setup seeks a Senior Director to lead the regulatory and medical writing function within ExploR&D, overseeing document development and IT tool support across clinical and regulatory programs.

The role requires strategic leadership, vendor and process management, and deep regulatory knowledge to support regulatory interactions and external collaborations across global trials.