Medical Writing Projects Director

Summary

Join Scholar Rock, a biopharmaceutical company focused on developing life-changing therapies, as their Medical Writing Projects Director - Nonclinical. You will be responsible for creating and managing the development of various nonclinical reports and documents for regulatory submissions, both in the US and internationally. This role requires a highly motivated professional with extensive experience in medical writing within the pharmaceutical/biotech industry, specifically in pharmacology, toxicology, and related fields. Success in this position hinges on strong project management skills, scientific writing expertise, and the ability to collaborate effectively with cross-functional teams. The ideal candidate will possess a Ph.D. or equivalent experience and a proven track record of successful drug application submissions to various health authorities. This position demands a high level of independence, creativity, and the ability to thrive in a fast-paced environment.

Requirements

• Ph.D. or equivalent level of experience in toxicology, pharmacology, drug metabolism and pharmacokinetics, or related biomedical/life sciences discipline
• 10+ years of experience in medical writing within the pharmaceutical/biotech industry, with at least 5+years at a sponsor company
• Experience and a proven track record of successful drug application submissions to US (FDA) and ex-US (EMA, MHRA, PMDA)health authorities
• Extremely strong project management skills; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
• Strong knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory science, and medical terminology
• Strong knowledge of requirements for the preparation of Module 4 nonclinical documents and Module 2 summaries for drug marketing applications
• Ability to work independently in a fast-paced, small biotech corporate environment
• Ability to be creative and innovative
• Common sense

Responsibilities

• Create and manage development of pharmacology, toxicology, PK/PD, GLP and bioanalytical reports (Module 4) as well as nonclinical sections of regulatory documents including, nonclinical Module 2 summaries, regulatory briefing documents, and nonclinical sections of regulatory submissions
• Lead project-level writing teams with minimal supervision
• Collaborate with cross-functional teams to drive document development, reviews, and timelines with a sense of urgency to meet aggressive corporate goals
• Lead and manage senior-level subject matter experts in the development of complex documents
• Represent Medical Writing on cross-functional teams and workstreams