Merck Senior Specialist, Planning & Scheduling in West Point, Pennsylvania
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
The main function of the Senior Specialist, Operations Planning is to coordinate both internal and external packaging orders through various work centers (label design/printing, packaging and quality) ensuring final release is achieved on time. In addition, the Operations Planner will serve as the subject matter expert on the logistics of all packaging jobs.
Primary responsibilities include and are not limited to the following:
Coordinates job progress (pre- and post-execution) across all applicable work centers.
Tracks project risks and implement mitigation plans.
Provides input and partners with other work centers to develop the packaging/labeling strategy for Clinical Supplies Specifications.
Prepares all documentation in accordance with study requirements including: SWMS requests, Batch Records, Bill of Materials and Recipes.
Recommends unique packaging solutions that meet clinical study needs.
Investigates and writes NOE’s in the event of deviations.
Is in contact to third party packaging companies and negotiates packaging timelines with contract manufacturers and requests/reviews quotes.
Provides input and partners with other work centers to develop the packaging/labeling strategy for the individual clinical products.
Monitors the adherence to project schedules and documents progress in respective databases.
Assists the work centers (Global Project Management, Packaging, Label Operations, Quality disposition group) for issue resolution as needed.
Collaborates with global master planning and project management (demand and supply project managers) to establish priorities across different projects
Education Minimum Requirement:
Bachelor’s degree in a scientific, business, or related discipline required.
Required Experience and Skills:
At least 3 years of experience in the pharmaceutical industry, preferably in a clinical supply related area (planning, scheduling, coordination, etc.).
Preferred Experience and Skills:
Strong verbal and written communication skills
Ability to organize and manage multiple tasks at one time and meet deadlines
Familarity with Good Manufacturing Practice requirements, quality procedures and Standard Operating Procedure execution
Above average proficiency in Microsoft applications (Word, Excel, PowerPoint)
Proven project management skills
Direct work experience with Standard Operating Procedure is a plus
Flexible and team-oriented
Diligent and quality-oriented
Structured and proactive working attitude
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 …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
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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No Travel Required
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R32924
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