Clinical SupplyProject Manager

Employer
Merck
Location
Rahway, NJ, US
Posted
April 17 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: PRO017089

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. 
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:
  • Chair the Clinical Supply Program Team (CSPT) and works closely with Clinical Trial Teams (CTT), Global Clinical Trial Operations ( GCTO) Project Management (PM), Regulatory, Global Quality Management ( GQM) and other functional area representatives to negotiate timelines and strategy for clinical supplies
  • Acts as the main spokesperson between Global Clinical Supply and Clinical Science & Study Management ( CSSM) for all clinical supply related issues
  • Interacts with various organizations such as CSSM, Regulatory, CMC, Phamaceutical and Biological  Development Teams and GQM  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 MRL and interdivisional meetings and reviews
  • 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.
  • Responsible for the clinical supply section of the study protocol
  • Responsible for the clinical supply budget for respective program(s) 
  • Participate in Interactive Voice Response System  Development and User Acceptance Training for given studies

 Qualifications

Education Minimum Requirement: Bachelor degree in a scientific , business or related discipline required. MS/MBA preferred.
Required Experience and Skills:
  • At least 2 years of experience in planning, scheduling, coordination of clinical supply activities or the equivalent. 
  • One year of project management experience.
  • Preferred Experience and Skills:
  • 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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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:              EEOC Poster             EEOC GINA Supplement

Job: Product Dev Proj/Prog Mgmnt - DPS
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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