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Senior Clinical Supplies Project Manager
ICON plcSenior Clinical Supplies Project Manager providing regulatory and technical support for global pharmaceutical supply. Overseeing supply management activities ensuring quality and compliance across project teams with significant CMC activities.
About the role
Key responsibilities & impact- Provides scientific, technical and regulatory support to projects that have significant Pharmaceutical Supply Management, Chemistry, Manufacturing and Control (CMC) activities associated with them.
- Acts as the lead on appropriate project teams.
- Manages global pharmaceutical supply for all phases and pharmaceutical development activities ongoing at contract facilities with respect to technical, quality, timing and cost standpoint on behalf of clients.
- Oversees labelling, packaging and distribution activities of CMO including review and approval of labelling / packaging records and distribution plans.
- Oversees recall, returns and destruction activities, as appropriate.
- Oversees the procurement of marketed drug product, such as comparators performed by an approved vendor and ensuring that all study specific regulatory requirements are met.
- Performs Batch Record Review and Approval, as applicable.
- Manages temperature deviation, product complaints and recalls, as delegated by the client.
- Conducts gap analysis of processes relating to pharmaceutical supplies for applicable project teams.
- Participates in discussions of objectives and scope of prospective projects with potential clients.
- Maintains confidentiality of management information as appropriate.
- Liaises with other managers to improve the effectiveness of the organisation.
- Undertakes other reasonably related duties as may be assigned from time to time.
- Travel (approximately 10%) domestic and/or international.
Requirements
What you’ll need- You must have 3 - 4 years experience of working within a Clinical Supplies Project Management role.
- Degree ideal.
Benefits
Comp & perks- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmaceutical supply managementchemistrymanufacturing and control (CMC)batch record reviewgap analysisregulatory requirementslabelingpackagingdistributionprocurement
Soft Skills
leadershipproject managementcommunicationconfidentialitycollaborationorganizational skills
Certifications
degree