Merck Associate Director, Clinical Supplies Project Manager in Helena, Montana
New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
Interacts with various organizations as a lead GCS Planning program representative such as Clinical Sciences and Study Management (CSSM), Regulatory, CMC, PharmSci, Development Teams, and Global Development Quality as necessary to address drug supply related topics
Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across assigned program(s)
Responsible and accountable for establishing the timelines for bulk manufacturing needs across assigned program(s)
Initiates drug supply projections in SAP for new studies in assigned program(s)
Responsible for the clinical supply budget for respective program(s)
Chairs the Clinical Supply Program Team (CSPT) and work closely with Clinical Trial Teams (CTT), Project Management (PM), Regulatory and other functional area representatives to negotiate timelines and strategy for clinical supplies across all assigned program(s)
Ensures GCS Planning Leadership is aware of program pipeline forecast to ensure proper resourcing of all levels of planning support
Responsible and accountable for utilizing key tools in the planning and managing of clinical supplies for assigned program(s). This may include Microsoft Project Plans, Actions, Issues and Risk (ADI) Logs, forecasting tools (SAP), etc.
Mentors new team members, as needed
May participate as an SME in an area of expertise
Bachelor’s degree in a scientific, business, or related discipline required, MS/MBA preferred
5+ years’ relevant experience in pharmaceutical and/or clinical drug development with experience in planning, scheduling, coordination and processing of clinical supply activities, or the equivalent
Excellent oral (including presentation) and written communication, project management, creative analytical and problem-solving skills
Demonstrates ability to negotiate, resolve conflicts and engage in decision making as well as 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 and procedures
Knowledge of order management, supply chain operations and document control
Ability to organize and manage multiple tasks at one time and meet deadlines
Familiarity with GMP requirements, quality procedures and SOP execution
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R147198