Associate Director, Comparator Management - HybridApply remote type Hybrid locations USA - Pennsylvania - West Point USA - New Jersey - Rahway time type Full time posted on Posted 7 Days Ago time left to apply End Date: December 17, 2024 (6 days left to apply) job requisition id R325129Job DescriptionThe Associate Director, Comparator Management is responsible for the sourcing and product management (assessment, order, delivery, release and applicable product blinding) of Non-Company commercial (comparator) products for all clinical trials. The incumbent will collaborate closely with internal customers including the Clinical Supply Project Managers (CSPM) and function as an independent expert in supply planning, product management and buyer of non-Company commercial products. Candidates should have proven strong expertise in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), commercial medicinal products and buying from external drug wholesalers specialized in comparator sourcing.Primary activities include, but are not limited to:
- Sourcing and product management for comparator products.
- Sourcing and procuring comparator samples and documentation for comparator label and packaging component evaluation.
- Creating and maintaining Material Masters and provide SAP Process Orders for de-packaging, pre-packaging, manipulation, and placebo manufacturing & packaging according to the routing.
- Managing comparator blinding including but not limited to de-printing and over-encapsulation.
- Effective communication with internal and external stakeholders.
- Forecasting comparator pricing information to enable accurate consolidated budget planning, expense forecasting and management.
- Maintaining oversight of shipping activities, monitoring target delivery dates and supporting release activities.
- Creating and maintaining Purchase Requests as well as requesting Purchase Orders in SAP.
- Utilizing systems to document/execute GxP activities.
- Promoting continual creative improvement and actively contribute to a culture of innovation, excellence and accountability.
- Providing mentoring and coaching to team members.
- Champion and drive identified business process improvement initiatives, as needed.Education:
- Bachelor's degree in the supply chain, scientific or business discipline.Required Experience & Skills:
- Minimum 5 years experience in clinical supplies or procurement with knowledge of comparator sourcing markets and processes.
- Knowledge of current Good Manufacturing and Distribution Practices (cGMP/GDP) and Standard Operating Procedure execution.
- Excellent verbal and written communication skills, and effective interactive skills to partner with various stakeholders.
- Ability to work effectively across boundaries to build strong collaborative relations with other internal and external partners.
- Competence in process optimization, including design and execution.
- Strong project management skills and ability to organize and manage multiple tasks at one time and meet deadlines.
- High proficiency in Microsoft applications (Word, Excel, PowerPoint, Teams).
- Experience with SAP.Preferred Skills:
- Project management certification (e.g. PMP, CAPM).
- Knowledge of Operational Excellence methodology such as Six Sigma and Lean methods principles and tools.US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. #J-18808-Ljbffr