The Medical Writing Projects Director - Nonclinical will be responsible for document development and managing medical writing activities and timelines for nonclinical reports and documents from regulatory/health authority drug marketing applications, including US (Investigational New Drug [applications], New Drug Applications, Biologics Licensing Applications) and ex-US (Clinical Trial Applications, Marketing Authorization Applications) submissions. This position requires a highly motivated professional with experience writing and managing the development of pharmacology, toxicology, Good Laboratory Practice, pharmacokinetics and pharmacodynamics reports, and Module 2 summaries for successful drug marketing applications. Key success factors include project management skills and scientific writing skills; integrative thinking with a team-centric collaborative mindset; ability to work independently and influence decision-makers; exceptional communication skills; work well under pressure in a fast-paced environment with tight deadlines.

Position 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

Candidate 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 summariesfor drug marketing applications
  • Ability to work independently in a fast-paced, small biotech corporate environment
  • Ability to be creative and innovative
  • Common sense