Job Description
Exceptional career development and advancement opportunity
Our client is a hugely successful rapidly expanding young organisation with a commercialised product that is exceeding all projections and forecasts in the US marketplace, along with an exciting pipeline comprised of mainly combination products.
Reporting to the Vice President, Technical Operations, this newly created position will lead Technical projects at external vendors with a focus on process Improvement / development to ensure successful completion of the project deliverables. The candidate will be expected to compile timelines, manage project budgets, complete prior knowledge reports, help with regulatory filings and patents etc.
Job Spec:
Manage assigned projects and schedules in coordination with the VP of Tech. Ops.
Manage formulation changes, scale up and testing of pharmaceutical dosage forms at third party manufacturers.
Support the drafting of regulatory CMC documentation such as pharmaceutical development reports.
Develop and track goals, project plans, timelines and budgets.
Facilitate issue resolution in a timely manner.
Manage budget processes for assigned projects including detailed reporting.
Ensure accurate tracking and reporting of project deliverables and milestones within a GxP environment.
Create and maintain consistent project documentation including reporting dashboards.
Drive action item follow-up.
Person Spec:
The preferred candidate will have a strong relevant academic profile along with two years proven track record in the delivery of Technical Services projects within drug development and/or an engineering background. Additional experience in delivering Tech Services projects in the medical device space a distinct advantage
Ability to exercise initiative and creativity in resolving project delivery related issues
Experience managing project/program budgets
Ability to manage project work plans, documentation and action item follow-up
Ability to perform in a fast-paced, fast growing environment with competing priorities under tight deadlines
Strong and proactive team player with good interpersonal skills
Strong organizational abilities and attention to detail
Strong written and verbal communication skills
Proficiency with MS Office (e.g. Project, Word, PowerPoint, Excel, Outlook)
CV to Gerry Kennedy The RFT Group gerry@rftgroup.ie 01 2302400