Job Description

The Clinical Supplies Project Manager (CSPM) organizes all activities involved with the management of clinical supplies. This includes but is not limited to the following services: procurement, formulation/development, manufacturing, packaging and analytical services. The CSPM serves as the primary business partner contact. It is the responsibility of the CSPM to define the scope and timing of the requested services. The CSPM coordinates all internal and external communication related to each project.

Essential Duties and Responsibilities

• Serve as the primary liaison for business partners
• Interview business partners to obtain all relevant project information
• Communicate and manage customer expectations
• Participate in Business development Handoff process
• Prepare project timeline with input from key operating departments and business partners
• Complete all applicable project documentation in a timely manner
• Identify components required as approved proposal and submit request to Purchasing
• Facilitate the Production Order creation in SAP
• Write Master Packaging Records (MPR) or work with Project Specialists on authoring records in compliance with cGMPs and SOPs in a timely and accurate manner
• Facilitate SmartSheet entry for ERP
• Enter and maintain SmartSheet workspace for Operations activities
• Document and ensure that all project information is maintained and placed in its corresponding project folder
• Facilitate Project meetings inclusive of agendas and minutes
• Ensure all required documents are available for expected customer receipts.
• Collaborate with key operating departments to meet internal dates for timely completion of requested activities
• Work with colleagues to resolve potential conflicts with projects
• Inform management and business partners of project delays and recommend appropriate solutions
• Support customer-facing activities as required for your clients/ projects
• Support the company’s mission and vision and contribute to the pursuit of the company's goals.
• Adhere to policies, processes and SOPs to ensure compliance with cGMP, FDA and any other regulatory regulations and standards
• Adhere to set safety standards
• Participate actively in regular meetings.
• Achieve expected performance measures
• Other duties as assigned

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelors’ Degree in the sciences and/or related experience
• 1-3 years in experience in Project Management, preferably in pharmaceutical industry
• Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines
• Excellent oral and written communication is required to communicate with the team, peers, management and external contacts
• Knowledge of cGMPs, FDA, DEA and OSHA Regulations and ISO guidelines, preferred
• Basic knowledge of drug product nomenclature and drug development process
• Strong ability to contribute and function in a team environment to achieve Company goals
• Working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel