Nonclinical Medical Writing Consultant

2 days ago

Cape Town, South Africa MMS Full time

This role is a project-based consulting opportunity and will participate in the development, writing, and management of Nonclinical-related documents.

**Roles and Responsibilities**:

- Strong experience with development and writing of Nonclinical-related documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents)
- Lead projects independently with mínimal oversight
- Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data
- Collaborate with cross-functional teams such as safety, biostats, CMC, and clinical
- Demonstrated ability to lead others to complete complex projects
- Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines
- Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
- Excellent written/oral communication and strong time and project management skills
- Ability to attend regular team meetings
- Strong understanding of regulatory guidances as it applies to nonclinical submissions (eg, NDAs, MAAs, INDs, IMPDs)
- Strong understanding of pharmacokinetics as it applies to nonclinical reports and nonclinical submission modules

**Requirements**:

- BS + in biology or chemistry, or related field, with industry experience within regulatory affairs, laboratory sciences, quality assurance/control
- Knowledge of GMP, ICH guidelines, and applicable regulatory requirements
- 2+ years of pharmaceutical regulatory Nonclinical writing experience
- Strong writing and analytical skills

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