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Clinical Supply Project Manager

Merck


Location:
West Point, PA
Date:
06/26/2017
2017-06-262017-07-26
Job Code:
PRO015753
Merck
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Job Details

Job Title: Clinical Supply Project Manager  - PRO015753

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 


Overview: 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 individual 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 the following:
  1. Chair the Clinical Supply Program Team (CSPT) and works closely with Clinical Trial Teams (CTT), Project Management (PM), Regulatory, and other functional area representatives to negotiate timelines and strategy for clinical supplies
  2. Acts as the main spokesperson between Global Clinical Supply and Clinical Development Execution Organization for all clinical supply related issues
  3. Interacts with various organizations such as Clinical Development Execution Organization, Regulatory, CMC, PSCS Development Teams and Quality as necessary to address drug supply related issues
  4. 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
  5. Responsible and accountable for establishing the timelines for clinical supply needs per project; and providing the signal for manufacturing, packaging, sourcing, etc.
  6. Analyzes and anticipates project risk as they relate to clinical supply chain and prepares analyses/mitigation for review at appropriate MRL and interdivisional meetings and reviews
  7. Responsible and 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.
  8. Responsible for the clinical supply section of the study protocol
  9. Responsible for the clinical supply budget for respective program(s) 
  10. Participate in Interactive Voice Response System Development and User Acceptance Training for given studies



Qualifications

Education: 
  • Bachelor degree in a scientific , business or related discipline required. 

Required: 
  • At least 2 years of experience in planning, scheduling, coordination of clinical supply activities or the equivalent. 
  • One year of project management experience.

Preferred:
  • Creative, analytical and problem solving skills
  • Strong interpersonal skills in verbal and written communication, ability to negotiate, resolve conflict, and engage in decision making to partner and influence across areas and organizations
  • Knowledge of clinical customer relationship management
  • Knowledge of order management, supply chain operation and document control
  • Above average proficiency in Microsoft applications ( Word, Excel, Powerpoint, Project)
  • Ability to organize, manage multiple tasks simultaneously, and reprioritize as needed all in an effort to meet deliverables
  • Knowledge of GMP requirements, quality procedures and SOP execution


Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            

            



Job Product Dev Proj/Prog Mgmnt

Primary Location NA-US-PA-West Point

Other Locations 

Employee Status Regular

Number Of Openings 1

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