Senior Project Manager, Clinical Supply

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Contribute insights to Clinical Study Teams to shape clinical protocol design and enhance supply chain efficiency.

• Transform clinical study designs into corresponding packaging solutions.

• Draft sections related to study medication and labeling in clinical protocols.

• Create protocol-specific labeling that adheres to global regulatory standards.

• Identify, develop, communicate, and monitor project timelines, activities, logistics, and milestones.

• Generate protocol-specific manufacturing and packaging work orders in collaboration with vendors, quality assurance, and clinical team partners.

• Ensure clinical supplies are available in a timely manner.

• Conduct scenario analyses, risk management, and contingency planning for clinical supplies.

• Anticipate requirements for bulk drug products, comparator agents, ancillary supplies, and commodities, including overages.

• Engage in cross-functional projects as a drug subject matter expert.

• Drive initiatives for process improvements.

⛳️ Requirements

• A Bachelor’s Degree is required, preferably in a field such as physical science, mathematics, engineering, or pharmacy.

• Experience in at least one of the following areas: Drug Discovery, Drug Development, Clinical Operations, Supply Chain, or Quality Assurance.

• Proficient in applying standard business requirements, including SOPs and global regulations.

• Familiarity with compliance in regulated environments.

• Ability to actively contribute to cross-functional projects.

• Strong collaborative skills across various departments and functions.

• Capable of managing and prioritizing multiple tasks under tight deadlines and high-pressure situations.

• Excellent problem-solving and project management abilities.

• Strong written and verbal communication skills.

• Preferred but not required: 3 years of experience in the pharmaceutical industry.

🏝️ Benefits

• Paid time off, including vacation, holidays, and sick leave.

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Availability of remote work options.

• Commitment to equal opportunity employment.

• Reasonable accommodations for applicants from the US and Puerto Rico.