- SalaryCompetitive
- LocationSydney
- Job type Contract
- DisciplineMedical Affairs
- ReferenceBH-39323
Back to jobs
Project Manager – Devices Vigilance Policy
Job description
Overview
Key Responsibilities
The Project Manager duties may include but are not limited to the following:
Tasks
- Contract role
- Competitive rates
- Inclusive and high performing team
Key Responsibilities
The Project Manager duties may include but are not limited to the following:
- Development of a risk based assessment framework in relation to surface texture for breast implants.
- Reinvigoration of the Action Plan Consumer Working Group to co-design consumer friendly documents which translate technical regulatory language into plain English to make documents more accessible to non-expert audiences.
- Support establishment of a separate Women’s Health Working Group.
- Support the post-market enhancements projects as required.
Tasks
- Analyse and review the Breast Implant Working Group papers and clinical evidence.
- Undertake research and work closely with Executive Level Officers and other internal stakeholders as required, on resolution of questions concerning the projects and working groups.
- Assist in drafting option papers as required to consider what could/should be implemented for:
- Internal consultation;
- Targeted consultation with RegTech and selected industry/consumer groups; and
- Consider consequences for industry, HCP, consumers (if any)
- Liaise with external stakeholders as required to invite new working group members or refresh existing members.
- Assist in preparing meeting papers, briefings and organise meetings, conflict of interest registers.
- Draft minutes and Communiques.
- Build relationships with consumer bodies and state and territories.
- Liaise with web publishing, regulatory education/guidance team to develop/draft external facing documents and consumer friendly artefacts.
- Undertake coordination and administration and other tasks as required, e.g. ad hoc briefing requests, development of educational materials.