Associate Director Medical Writing
Novotech · AU
The Associate Director Medical Writer is primarily responsible for medical writing projects and operations, oversight in high-quality and timely delivery of...
Job description
About the Role: The Associate Director Medical Writer is primarily responsible for medical writing projects and operations, oversight in high-quality and timely delivery of medical/scientific writing products to clients. The core responsibilities include overseeing MW compliance with applicable regulations, guidelines, developing and implementing best-in-class policies, procedures and practices, overseeing client interactions and contributing to the education and training of MW staff. The Associate Director Medical Writer will cross-collaborate with colleagues from Operations, Finance, IT and Business Development to ensure business continuity; liaise with alliance partners, external contractors, if applicable; be responsible for ensuring audit inspection readiness. Minimum Qualifications & Experience: Degree in a biomedical field or equivalent. Advanced degree(s) in a scientific discipline (Ph.D., MD, or Pharm. D.) preferred. 5+ years direct Medical Writing experience in the pharmaceutical industry (i.e. preparation of a broad range of clinical/regulatory documents including Clinical Study Reports, Protocols, Regulatory Submission Modules, Safety Aggregate Reports and Manuscripts)....