An innovative pharmaceutical company who offers biotechnological medicinal products and manufactures film-coated tablets, oncological drugs, and more, is looking to bring on new talent to assist its project management and supply chain needs. The Supply Chain & Technical Operations team is looking for a Clinical Supply Operations Manager who will help manage and improve technical facets of drug packaging and distribution to provide patient-friendly designs. This role will require drug supply forecasting, label generation, budget management, and vendor selection/management.
Responsibilities
- Collaborate with relevant teams to ensure project objectives align
- Drive label creation and approval process for all potential participants project-to-project
- Generate Requests for Proposal (RFPs) to support supply strategy
- Provide budget management project-to-project and employ cost-saving strategies when appropriate
- Monitor recruitment, drop-outs, and need for supplies as it pertains to needs of the project
- Support regulatory filings and audits to comply with protocol requirements
Qualifications
- 5 years of related experience preferred
- BS in Pharmacy or a related field
- Experience in Project Management, Clinical Supply Management, and/or Pharmaceutical Development
- Experience managing third-party contract clinical supply operations
- Working knowledge of Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs) across multiple therapeutic areas
- Experienced with techniques and approaches to support various clinical trial designs
- Working knowledge of import/export regulations at a global level as well as Investigational Medicinal Product (IMP) requirements
This is a remote 12-month to hire (FTE) position.
Highly competitive pay + full benefits
