Clinical Supply Associate ll

Job Summary:

Clinical Supply Associate will be responsible for supporting the Clinical Supply Program for clinical studies, including planning, management, and tracking activities related to Clinical Trial Material (CTM). The Clinical Supply Associate will also assist in the development and maintenance of internal processes and procedures.

Essential Duties & Responsibilities

• Collaborating cross-functionally with the Clinical Operations, Manufacturing, Regulatory Affairs, and Quality Assurance departments to plan and execute medical supply planning, including labeling and packaging, inventory control, and depot management for assigned clinical studies
• Working with clinical study teams to coordinate and facilitate investigational drug and ancillary supplies for study sites
• Liaising with depots and Contract Research Organizations (CROs) to ensure proper inventory levels needed for clinical trials and tracking product expiration
• Engaging with Clinical Program Managers regularly to ensure completion of project goals in line with deadlines
• Preparing, maintaining, and tracking purchase requisitions/purchase orders and costs with vendors
• Contributing to processes and tools in document management systems to ensure quality
• Assisting in development of product labels for clinical supplies, including master label text and subsequent reviews, approvals, and translations
• Engaging with CROs and project teams in study-wide setup and utilization of Interactive Response Technology (IRT) systems for allocating site and depot supply levels in accordance with study needs
• Assisting in operational compliance with relevant regulatory and quality standards in accordance with federal and international requirements
• Supporting the Clinical Supply Senior Manager in activities including, but not limited to:
  • Forecasting of clinical supply needs for projects across full-study timelines
  • Development and maintenance of Standard Operating Procedures (SOPs), work instructions, processes, and forms
  • Preparation of materials, such as study pharmacy manuals, for presentation at Investigator Meetings
  • Collaboration with the Chemistry, Manufacturing and Control (CMC) project leader to estimate and define supply strategy
  • Facilitation of import and export documents such as: import licenses, special permits, Proforma invoices, and additional documentation required to transport CTM to final destinations
  • Review of clinical supply packaging and labeling records, and trial supply sections of all relevant clinical documents
  • Coordinating returns and destruction of investigational product at sites and depots
• Supporting the Clinical Supply Senior Manager in supply chain and trial-related operational and logistical activities as requested.

Supervisory Responsibilities:

• N/A

Knowledge & Other Qualifications:

• 2+ years of experience with a bachelor's degree in a life sciences or health-related field
• 5+ years of relevant experience with High School Diploma considered.
• 1+ years relevant pharmaceutical, biotechnology, and/or life sciences experience preferred
• Experience with enterprise resource planning (ERP) software such as Microsoft Dynamics AX, Oracle JD Edwards, and SAP
• Familiarity with regulatory health authorities (e.g., FDA, EMA) and Good Clinical Practice (GCP) guidelines
• Strong organizational skills with excellent attention to detail
• Excellent interpersonal and communication skills in English language
• Advanced proficiency of Microsoft Office package including Word, and Outlook, and Excel
• Experience with investigational drug product primary/secondary packaging and labeling processes
• Contracts and vendor management experience
• Detail-orientated and process focused
• Work effectively with team members across all levels of the organization
• Able to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines

Other Characteristics:

• Proven initiative and work ethic
• Comfort working with data and data analysis
• Ability to problem-solve and propose solutions based on limited information/guidance
• Ability to work with various stakeholders to achieve desired goals
• Capable of being innovative and dynamic in approach to work
• Authorized to legally work in the United States without visa sponsorship

Physical Requirements / Work Environment

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading
• The worker is not substantially exposed to adverse environmental conditions

Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.