Contract Regulatory Medical Writer

Hours per week: 20 - 40

This is a remote, contract medical writing opportunity to work with one of the world's largest drug development consultancy.

Responsibilities:

Collaborate with client and internal teams to develop strategies for regulatory document organization
Lead project teams in the development of high-quality documents (study-level and submission level)
Author documents according to client specifications and regulatory authority guidelines
Author all clinical and regulatory documents (ex: IND, NDA, CSRs, IBs, protocols, etc.)
Serve as a client advisor, fostering strong relationships through effective communication
Maintain proactive communication with clients and internal teams
Lead project-related meetings and teleconferences

Qualifications:

Bachelor’s degree; MS or PhD preferred
8+ years of regulatory writing experience with expertise in clinical sections of the CTD
Familiarity with regulatory authority guidelines and requirements
Experience in developing submission-level documents