Senior Specialist, Clinical Supplies Project Manager
Working independently, the Clinical Supplies Project Manager (CSPM) designs strategic and operational plans for all activities associated with clinical supplies during the development process of a compound This position may be responsible for clinical supplies programs of varying complexity. This position serves as the primary Global Clinical Supply point of contact to customers and as the Global Clinical Supply spokesperson at clinical development-related meetings (i.e. Clinical Supply Program Team, Clinical Trial Team, Clinical Development Sub-Team) and product development related meetings.
Primary activities include, but are not limited to:
Chair the Clinical Supply Program Team (CSPT) and works closely with Clinical Trial Teams (CTT), Project Management, Regulatory, and other functional area representatives to negotiate timelines and strategy for clinical supplies
Acts as the main spokesperson between Global Clinical Supply and Clinical Development Execution Organization for all clinical supply related issues
Interacts with various organizations such as Clinical Development Execution Organization, Regulatory, Chemistry, Manufacturing, and Control (CMC), Pharmaceutical Sciences & Clinical Supply (PSCS) Development Teams and Research Commercialization Quality as necessary to address drug supply-related issues
Plans the progress of a product throughout the development life cycle, from designation as a Preclinical Candidate (PCC) through Phase IVN marketing studies, as it relates to clinical supply needs; plans for both in-house and in-licensed compounds
Responsible and accountable for establishing the timelines for clinical supply needs per project; and providing the signal for manufacturing, packaging, sourcing, etc.
Analyzes and anticipates project risk as they relate to clinical supply chain and prepares analyses/mitigation for review at appropriate Research and Development (R&D) and interdivisional meetings and reviews
Accountable for utilizing key tools in the planning and managing of clinical studies. This may include Microsoft Project Plans, Actions, Issues and Risk Logs, forecasting tools, etc.
Responsible for the Clinical Supplies section of the study protocol
Responsible for the clinical supply budget for the respective program(s)
Participate in Interactive Voice Response System Development and User Acceptance Training for given studies
Bachelor's degree in a scientific, business or related discipline; MS/MBA preferred.
6+ years of relevant work experience.
At least 2 years of experience in planning, scheduling, coordination and processing of clinical supply activities, or the equivalent.
At least 1 year experience in project management.
Qualifications and Skills:
Creative analytical and problem-solving skills
Excellent interpersonal and communication (verbal and written) skills, ability to negotiate, resolve conflicts and engage in decision making to partner and influence across functional areas and organizations
Knowledge of project management and Clinical customer relationship management
Knowledge of drug development, destruction, reconciliation, distribution and shipping processes & procedures
Knowledge of order management, supply chain operations, and document control
High proficiency in Microsoft Office suite (Word, Excel, PowerPoint,)
Ability to organize and manage multiple tasks simultaneously and meet deadlines
Familiarity with Good Manufacturing Practice (GMP) principles, quality procedures, and Standard Operating Procedure (SOP) execution
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.
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Flexible Work Arrangements:Remote Work
Shift:1st - Day
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Number of Openings:4