Job Description

Primarily works at project level May oversee contingent workers and/ or vendors; may provide training to others as needed Offers leadership and basic accountability, provides strategic assistance, and planning support for clinical regulatory documents Writers and edits clinical regulatory documents, including submission summaries and other complex documents Ensures that these documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards May participate in the preparation/revision of document templates Your experience and qualifications Phd or PharmD in life sciences (or other related field), or Master s degree in life sciences (or other related field) PhD or PharmD with a minimum of 2 years of experience OR Master s degree with a minimum of 4 years of experience