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 for their assigned study, which could vary in complexity. This individual serves as the primary GCS point of contact to customers both internal and external to GCS and serves as the GCS spokesperson at clinical development related meetings (i.e., Clinical Trial Teams) and product development related meetings. The incumbent is expected to have an understanding of concepts of clinical research and/or clinical supply chain activities, sound collaboration skills, and a demonstrated ability to drive/influence results in a dynamic environment.

Primary activities include, but are not limited to:

• Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.
• Interacts with key partner organizations such as Clinical Sciences and Study Management (CSSM), Regulatory, Chemistry, Manufacturing and Controls (CMC), Pharmaceutical Sciences, Formulation Development, and Global Development Quality to address clinical supply related topics.
• Responsible and accountable for establishing the timelines for clinical supply needs per project and providing the signal for sourcing, manufacturing, packaging, and distribution for our company's development products and non-company marketed products.
• Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders.
• Responsible and accountable for utilizing key tools in the planning and managing of clinical supplies for assigned studies.
• Works directly in the SAP system to establish a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).
• Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support critical CMC activities.
• Responsible for authoring the Clinical Supplies section of the study protocol as well as preparation and presentation of the clinical supplies information at Investigator Meetings for assigned protocols.
• Support the collection of clinical supply chain metrics to describe business health and the identification of areas for operational improvement.
• Participate in Interactive Voice Response (IVR) System development and User Acceptance Testing (UAT) for assigned studies.
• Participate in critical non-pipeline activities in support of clinical supply planning group (e.g., process improvement initiatives, subject matter expert roles, cross functional projects, etc)

Minimum Education required:

• Bachelor's Degree in business, supply chain management, engineering or scientific discipline required.

Required Experience and Skills:

• At least 2 years of experience in project management
• At least 2 years of experience in planning, scheduling, coordination and processing of supply chain activities, or the equivalent
• Basic understanding of material requirements planning (MRP) systems and demand planning principles
• Strong organizational, time management and problem solving skills
• Strong written and verbal communication and relationship skills along with high personal integrity, credibility, and energy.
• Ability to prioritize tasks and initiatives appropriately to mitigate supply risks.
• Proficiency in Microsoft Excel, PowerPoint, and Word.

Preferred experience and Skills:

• Results-orientation with the proven ability to execute on collaborative projects and develop subject matter expertise
• 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, production, distribution, shipping, destruction, and reconciliation processes and procedures.
• Knowledge of order management, supply chain operations and document control.
• Specific knowledge of clinical supply chains and their unique challenges.
• Familiarity with SAP as an Enterprise Resource Planning (ERP)/MRP system.
• Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution.

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NOTICEFORINTERNALAPPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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Expected salary range:
$111,400.00 - $175,300.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R278428